MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. IV3000 1 HAND 6X7CM CTN 100; TAPE AND BANDAGE, ADHESIVE

Model Number 66024007

Device Problem Difficult to Remove (1528)

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

Event Date 11/11/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during treatment, the paper part of the iv3000 1 hand 6x7cm, ctn 100 is not separating easily from the plastic film part of the dressing.It is unknown how treatment was resumed.Patient was not harmed as consequence.

Manufacturer Narrative

It was reported that the paper part of the dressing is not separating easily from the plastic film part of the dressing.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.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 the finished product specification.There was also no issue identified during the manufacturing process that could have caused or contributed to the complaint problem.A complaint history review revealed a small number of 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 although it contains several failure modes that can result in increased adherence to other materials.No update to the risk files is required.Probable root cause is that the dressings have been stored in the incorrect conditions and not in accordance with the ifu.The devices must be stored in the conditions outlined to prevent environmental factors such as temperature from affecting them.An increase in temperature above that recommended may affect the adhesive nature of the device, which can cause issues such as those described in the event.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.

• Brand Name: IV3000 1 HAND 6X7CM CTN 100
• 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: 12898221
• MDR Text Key: 284835028
• Report Number: 8043484-2021-01984
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 05000223417383
• UDI-Public: 05000223417383
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2023
• Device Model Number: 66024007
• Device Catalogue Number: 4007
• Device Lot Number: 2043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2020
• 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
• Patient Sex: Female