Labeling – potential field action?

[Jkc3usc12]

Looking for some insight on an issue that we came across with labeling on a product. Everything is correct on the label (no possible risk) – the only issue is the barcode/qr code do not scan. Customers can still enter the data manually it just doesn’t allow the scan. We have a fix for the issue.

The reg says - when a manufacturer takes a correction or removal action to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Thoughts?

 

[LUFAN]

What is the barcode? a UDI? or something to scan a SN for inventory?

 

[Jkc3usc12]

What is the barcode? a UDI? or something to scan a SN for inventory?

yes, so we found there isnt a space needed in the UDI, for it to be correctly scanned. All data on the product is correct you just cant scan. So the customers can enter manually just doesnt read if you scan.

 

[LUFAN]

yes, so we found there isnt a space needed in the UDI, for it to be correctly scanned. All data on the product is correct you just cant scan. So the customers can enter manually just doesnt read if you scan.

After initiating a CAPA, you'll want to perform containment and initiate a voluntary recall/removal and follow the requirements listed in 21CFR7. As you're not able to communicate data via an Automatic Identification and Data Capture (AIDC) method, that label is not conforming to 21CFR801 and 21CFR830. During your risk assessment, you'll need to determine if the criteria you mentioned with 21CFR806 would apply. Only your company can make that judgement.

Your CAPA will be important to ensure that doesn't happen again. My old company used to scan at least one of them per manufacturing lot after validating the software. If one was wrong/right, they all would be, etc.

 

[Jkc3usc12]

After initiating a CAPA, you'll want to perform containment and initiate a voluntary recall/removal and follow the requirements listed in 21CFR7. As you're not able to communicate data via an Automatic Identification and Data Capture (AIDC) method, that label is not conforming to 21CFR801 and 21CFR830. During your risk assessment, you'll need to determine if the criteria you mentioned with 21CFR806 would apply. Only your company can make that judgement.

Your CAPA will be important to ensure that doesn't happen again. My old company used to scan at least one of them per manufacturing lot after validating the software. If one was wrong/right, they all would be, etc.

Thats the dilemma there is no risk to product or patients. No risk of miss information. This is just an inconvenience that they cant scan it and need to manually enter it.

A CAPA will be opened.

 

[yodon]

If there's not enough space for the barcode, is there enough space for a readable (text) UDI?

There is a compliance risk (UDI is a regulatory requirement), so I wouldn't wave it off completely. It is a failure in labeling. Adverse events may get misreported, too.