MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. IV3000 1 HAND 6X7CM CTN 100; DRESSING,WOUND,OCCLUSIVE

Catalog Number 4007

Device Problem Defective Device (2588)

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

Event Date 03/14/2020

Event Type  malfunction  

Event Description

It was reported that the customer applied the product on her child's insulin pump but it only lasted a few hours and they wasted a pump because they had to find a different one to use.The product was ordered through amazon and the customer have not had any issues in the past.

Manufacturer Narrative

The device used in treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.As the product was not returned physical inspections and evaluations could not be undertaken.Images provided confirmed the part and lot numbers.Review of the manufacturing records found: no issue at the point of manufacture which may have caused or contributed to the issue highlighted by the complainant.In addition it can be confirmed that all finished product specification testing was satisfied at the point of release.Review of complaint history found further similar instances.At this time there are no indications to suspect that the device failed to meet manufacturing specifications upon release into distribution.The investigation into your complaint is now complete and has been recorded as: insufficient information to determine root cause.Potential causes for the issue experienced are: low adhesion may be caused by adhesion levels of the raw material used to make the film of this dressing.There are various controls in place during the manufacturing process of both the raw material and the dressing to identify when the adhesion is not in acceptable range, as per the product specification.There are also regular tests carried out to monitor the finished product.- as with all adhesive products, the skin must be thoroughly cleaned and dried prior to application.If there is any moisture on the skin the adhesive properties of the film may be compromised.As no manufacturing, material or design issues were identified, no further investigation or additional actions are required at this time.

• Brand Name: IV3000 1 HAND 6X7CM CTN 100
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 9944728
• MDR Text Key: 187761187
• Report Number: 8043484-2020-00277
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2022
• Device Catalogue Number: 4007
• Device Lot Number: 1908
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 8 YR