MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. IV3000 WINDOW FRAME 6X7CM CTN 100; TAPE AND BANDAGE, ADHESIVE

Catalog Number 59410082

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2019

Event Type  malfunction  

Event Description

It was reported that the dressing was not adhesive so the insulin pump needle fell.

Manufacturer Narrative

We have now concluded our investigation into this complaint.The batch records were reviewed and it could be confirmed that the products had progressed through a satisfactory release process which involved testing the product against the requirements of its finished product specification.There was no issue identified during the manufacturing process that could have caused or contributed to the issue.Due to no sample, no thorough investigation can be carried out.No true root cause can be identified for this issue, however a potential root cause is due to the adhesive processing of the product.Generally, where more adhesive is present, the adhesive performance is increased.During the adhesive spreading process, in-process checks are undertaken for this product.Each roll of adhesive spread material is checked to ensure the correct adhesive weight has been applied.Only product meeting the release criteria will be passed on for further processing.In the absence of additional information, our investigation remains inconclusive.At this time an exact root cause cannot be determined.If additional information becomes available in the future, this case will be reopened.

• Brand Name: IV3000 WINDOW FRAME 6X7CM CTN 100
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 8589365
• MDR Text Key: 144406044
• Report Number: 8043484-2019-00318
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• 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: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 59410082
• Device Lot Number: 1811
• Date Manufacturer Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1