MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO 7 15CM X 15CM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66802005

Device Problems Loss of or Failure to Bond (1068); Gas/Air Leak (2946)

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

Event Date 03/24/2021

Event Type  malfunction  

Event Description

It was reported that a new pico 7 kit was opened for application to a patient.After application, the machine was unable to seal, always leaking, thus maintaining the dressing without any negative pressure.Another machine from another kit was applied and started working right away.Customer informed that a large part of the silicone of the dressing was stuck to the film and not to the dressing, which may have caused the fact that the machine was unable to make the vacuum due to sealing.

Manufacturer Narrative

The device, 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.Silicone offsetting may cause dressing cannot be tightly adhered on skin, which may result in the inability to make a vacuum, so potential factors that can contribute to the reported event include the wound contact layer raw material quality issue.A review of the associated batch manufacturing records confirmed that the device met manufacturing specifications at the point of release.The complaint history review found further instances of the reported event.This investigation is now complete with no further action deemed necessary.We will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: PICO 7 15CM X 15CM
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11683379
• MDR Text Key: 245995060
• Report Number: 8043484-2021-00861
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K111170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/01/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 66802005
• Device Lot Number: 202037
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/25/2021
• Initial Date FDA Received: 04/18/2021
• Supplement Dates Manufacturer Received: 05/21/2021
• Supplement Dates FDA Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1