MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO SINGLE USE NPWT 10X20CM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66800951

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/16/2019

Event Type  malfunction  

Event Description

It was reported that that the nurse went to assess 2 separate patients in the tcu and the port had been completely detached from the dressing, leaving a hole in the dressing where the port would normally be anchored.The problem was solved by removing the dressings and the impact caused was that the patients didn¿t receive the negative pressure as hoped for.

Manufacturer Narrative

H2,h6: we have now concluded our investigation into this complaint.No valid lot number was provided, therefore a review could not be carried out to confirm that the product had been manufactured in accordance with defined procedures and specifications.No samples were returned for analysis, however visual inspection of the provided photograph confirms that the soft port has come away from the pico dressing.Without return of the sample relating to the complaint, a root cause analysis cannot be carried out to find a potential cause for this issue.During the manufacturing process, regular tests are used to ensure that the machine which sticks the soft port to the dressing is working as it should.These tests include pull tests, where a weight is attached to the end of the soft port to make sure that the strength of the bond is up to specifications, and a leak test, to check that the adhesive which hold the two components together doesn¿t have any gaps in it.If these tests don¿t meet specifications, the product is not released to market.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: PICO SINGLE USE NPWT 10X20CM
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull ; UK
• MDR Report Key: 8681379
• MDR Text Key: 147455334
• Report Number: 8043484-2019-00389
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66800951
• Date Manufacturer Received: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1