MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. SKIN-PREP WIPES BULK 1 CASE 01; BANDAGE, LIQUID, SKIN PROTECTANT

Catalog Number	420471
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the skin-prep product have seal integrity issues.It is unknown if a backup was available and if a patient was involved.
Additional Manufacturer Narrative
H3, h6: the device intended to be used in treatment 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, probable root causes may include operator error during manufacturing process.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture, a complaint history review found further instances of the reported event.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: SKIN-PREP WIPES BULK 1 CASE 01
• Common Device Name: BANDAGE, LIQUID, SKIN PROTECTANT
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11617700
• Report Number: 8043484-2021-00765
• Device Sequence Number: 19749839
• Product Code: NEC
• UDI-Device Identifier: 30040565116519
• UDI-Public: 30040565116519
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/12/2023
• Device Catalogue Number: 420471
• Device Lot Number: 08890
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1