MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE POST-OP VISIBLE 15 X 10 CTN 20; TAPE AND BANDAGE, ADHESIVE

Model Number 66800137

Device Problem Unsealed Device Packaging (1444)

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

Event Date 11/18/2021

Event Type  malfunction  

Event Description

It was reported that, the packaging of a opsite post-op visible 15 x 10 ctn 20 is not closed properly so that the dressing is no longer sterile.It is unknown whether this problem was noticed in a therapeutic environment or not; therefore, patient involvement has not been confirmed.

Manufacturer Narrative

Internal complaint reference (b)(4).

Manufacturer Narrative

The device was not returned for evaluation.All provided information has been reviewed and we have not been able to establish a relationship between the device and the reported event or determine a root cause.On-line 100% visual inspection carried out by operators will remove unsealed dressings.Probable cause may include operator error during inspection.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history review found no further instances of the reported event.The risk files mitigate the reported issue with no updates required.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.

Manufacturer Narrative

H3, h6: the device was returned for evaluation.The dressing pouches returned were visually inspected and found the opposite side to the lead-in side were partially open, establishing a relationship between the device and the reported event.The lacquer transfer of the open seal areas were in place, indicating the pouches were originally well sealed.The smooth arc shape of open seal areas shows the seals were burst from the inside out.Probable causes include that the pouches experienced unexpected high pressure after shipment and the air inside pouches burst the pouch seals open.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history review found no further instances of the reported event.The risk files mitigate the reported issue 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 15 X 10 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: 12972485
• MDR Text Key: 282117465
• Report Number: 8043484-2021-02008
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 05000223463076
• UDI-Public: 05000223463076
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 66800137
• Device Catalogue Number: 66800137
• Device Lot Number: 202123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1