MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. IV3000 1 HAND 10X12CM CTN 50; TAPE AND BANDAGE, ADHESIVE

Model Number 66024008

Device Problems Problem with Sterilization (1596); Physical Resistance/Sticking (4012)

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

Event Date 12/24/2021

Event Type  malfunction  

Event Description

It was reported that, during treatment, 40 dressings of iv3000 1 hand 10x12cm ctn 50 were stuck with the package so sterility could not be assured.It is unknown how the procedure was completed or it caused any delay.No harm to the patient was reported as a consequence of this problem.

Manufacturer Narrative

Internal complaint reference (b)(4).

Manufacturer Narrative

H3, h6: the device, used in treatment, was returned for evaluation.The pouches for the dressings were sealed and intact.Upon opening the pouches were difficult to open and tore which risked compromising the dressing within.This meant it was possible to establish a relationship between the device and the reported event.It was not possible to determine a definitive root cause.There is nothing to indicate that the device was responsible for the event.The batch record was 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 found only one further instance of the reported event in the last 3 years.This is within acceptable rates of occurrence.It was reported that when opening the pouches were stuck to the dressing within so sterility could not be assured.Probable root cause is that the dressing has not been stored in the conditions outlined in the ifu.As temperature can alter the adhesive nature of the seal of the pouch the device should be stored in the optimum conditions as indicated in the ifu.The ifu contains comprehensive instructions on the safe operation and use of the device including the correct conditions in which the dressing should be stored.The alleged failure mode and any associated harm is mitigated in the risk files for this product.This investigation is now complete with no corrective actions required.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: IV3000 1 HAND 10X12CM CTN 50
• 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: 13236917
• MDR Text Key: 283683079
• Report Number: 8043484-2022-00026
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 05000223417406
• UDI-Public: 05000223417406
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2023
• Device Model Number: 66024008
• Device Catalogue Number: 4008
• Device Lot Number: 2031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1