MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKN IV3000; TAPE AND BANDAGE, ADHESIVE

Catalog Number UNKN05003901

Device Problem Difficult to Remove (1528)

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

Event Date 11/11/2021

Event Type  malfunction  

Event Description

It was reported that the paper part of the iv3000 dressing is not separating easily from the plastic film.It never used to be this way and started being noticed in the past 2-3 months.This information has been provided as a general feedback as it is not possible to obtain an estimate of events in which this has been noticed during treatment.Further information is not available.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H10: it was reported that the paper part of the iv3000 was not separating easily from the plastic film.No further information was provided.The device was used for treatment and was not returned for analysis.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.As no lot number was provided it was not possible to carry out a device history review.A complaint history review revealed no similar instances in the last three years.A risk management review concluded that without further information the alleged failure mode and any associated harm can not be directly linked to a specific failure mode within the risk file, however it does contains several failure modes which can result in an increased adherence to other materials.No updates to the risk files are required.Probable root cause is that the device has not been stored in accordance with the conditions outlined in the ifu.Environmental issues such as temperature can alter the adhesive nature of the dressings causing them to stick to the backing paper in this way.The users of the reported product are advised to consult the ifu, to prevent future occurrences of the reported issue.This guide provides comprehensive instructions of the operation, use and limitations of the device, including the correct conditions in which the device must be stored.This investigation is now complete, with no corrective actions required.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.Internal complaint reference number: (b)(4).

• Brand Name: UNKN IV3000
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12937161
• MDR Text Key: 282558608
• Report Number: 8043484-2021-01993
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/19/2022

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: UNKN05003901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 12/06/2021
• Supplement Dates Manufacturer Received: 04/13/2022
• Supplement Dates FDA Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1