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

Model Number	66024007
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during use, the iv3000 was found unfold and stuck together.It is unknown how the problem was solved.No patient complications reported.
Additional Manufacturer Narrative
H10: it was reported that, during use, the iv3000 was found unfold and stuck together.It is unknown how the problem was solved.No patient complications reported.The device was used for treatment and was returned for analysis.26 dressing pouches were returned.1 contained a folded dressing as described in the complaint.1 pouch was open and had the number 1 backing paper present only and 3 pouches were open and empty.The other remaining dressings were as expected and functioned as intended.Due to the folded dressing being present 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 no similar instances in the last three years.A risk management review concluded that the sequence of events described in this complaint are not contained in the relevant risk files.There is insufficient information within the complaint description and further information included in this complaint to provide a causal link between events and the product therefore no update to the risk files is warranted.As the event was described as happening during use even though external to patient, the most probable root cause is that the backing papers have not been removed in accordance with the ifu.If not removed in the right order the device can unfold and stick to itself as described in this case.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.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: case-2022-00092379-1.

• Brand Name: IV3000 1 HAND 6X7CM CTN 100
• 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: 13664255
• Report Number: 8043484-2022-00089
• Device Sequence Number: 20202353
• Product Code: KGX
• UDI-Device Identifier: 05000223417383
• UDI-Public: 05000223417383
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2022

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: 04/01/2023
• Device Model Number: 66024007
• Device Catalogue Number: 4007
• Device Lot Number: 2018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2020
• 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