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

Model Number	59410882
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during set up for iv therapy, when removing the backing paper of two (2) iv3000 10cm x 12cm central line catheters dressings, it was noticed that there were damages arrayed in linear disposition, following the dressing pattern, with a small hole on the surfaces.The iv therapy was completed using a smith and nephew back up device.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
It was reported that the dressing had damage arrayed in linear disposition, following the dressing pattern with small holes on the surface.The device was used for treatment and was returned for analysis.The samples were as described in the complaint which meant we have been able to confirm a relationship between the event and the device.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.There is nothing to indicate that this is outside of acceptable rates of occurrence.The risk files, mitigate the reported issues with no updates required.Root cause has been traced to an issue during manufacture.On occasion, debris may stick to a roller that the film goes around and when the film then lifts from the roller, parts of it adhere to the debris, causing damage to the film.Checks are in place to prevent this issue and the roller is periodically cleaned to remove any debris.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 WINDOW FRAME 10X12CM CTN 50
• Common Device Name: 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: 12203231
• Report Number: 8043484-2021-01647
• Device Sequence Number: 14212260
• Product Code: KGX
• UDI-Device Identifier: 00040565120607
• UDI-Public: 00040565120607
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2023
• Device Model Number: 59410882
• Device Catalogue Number: 59410882
• Device Lot Number: 2034
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2021
• Supplement Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 04/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown