MAUDE Adverse Event Report: 3M COMPANY 3M DURAPORE SURGICAL TAPE; TAPE AND BANDAGE, ADHESIVE

Catalog Number 1538-118

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/19/2024

Event Type  malfunction  

Event Description

Angiosystems received a voluntary recall from 3m for product 1538-118.We were informed the product had been incorrectly labeled with its expiration date.After reviewing we determined we had purchased one the impacted lot numbers 33pkln.We reviewed our production files and determined we had one customer who had received the recalled product.The customer was notified and they decided to discard the impacted tape in their possession.We had completed kits in our possession and we relabeled those kits with the corrected expiration date.We also had tape in bulk component inventory and we corrected the expiration date on the box to 5/23/2026 as instructed.

• Brand Name: 3M DURAPORE SURGICAL TAPE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): 3M COMPANY
• MDR Report Key: 19143024
• MDR Text Key: 340739754
• Report Number: MW5154004
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 1538-118
• Device Lot Number: 33PKLN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2024
• Patient Sequence Number: 1