MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE POST-OP VISIBLE 21X11CM JP CTN 20; TAPE AND BANDAGE, ADHESIVE

Catalog Number 66800145

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 11/29/2023

Event Type  malfunction  

Event Description

It was reported that, during set up or inspection for treatment, when a pouch was taken out of the carton of one (1) opsite post-op visible 21x11cm jp ctn 20, it was confirmed the dressing was trapped in the sealing part of the pouch.A picture of the damaged dressing seems to show a potential sterility breach; however, this will be confirmed after investigation.The procedure was resumed, without any delay, using a s+n back-up device.Patient was not injured as consequence of this problem.

Manufacturer Narrative

H10: internal complaint reference (b)(4).

Manufacturer Narrative

The device was returned and evaluated.Visual inspection found the dressing was trapped in the side seal of the pouch, confirming a relationship between the device and the reported event.The manufacturing process was reviewed.Dressings are fed onto packaging machine, sealed and cut into pouches.Dressing pouches are 200% visually inspected to ensure the devices that do not meet specification are removed.The root cause is a human inspection failure.A review of the associated batch manufacturing records did not identify any issue at the point of manufacture which may have caused or contributed to the reported event.In addition it can be confirmed that finished product specification was satisfied at the point of release.The complaint history review confirms there is a small number of similar event.A risk management review concluded that the alleged failure mode and any associated harm has been anticipated within the risk file, with no updates required.A review of prior escalation actions found no actions applicable to the scope of this case.This investigation is now complete with no further action deemed necessary.Smith and nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: OPSITE POST-OP VISIBLE 21X11CM JP CTN 20
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18402499
• MDR Text Key: 331437894
• Report Number: 8043484-2023-00093
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K852211
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2024

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 Operator: Health Professional
• Device Catalogue Number: 66800145
• Device Lot Number: 202323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 02/22/2024
• Supplement Dates FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1