MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. IV3000 SHAPED 12X9CM CTN 50; TAPE AND BANDAGE, ADHESIVE

Model Number	66004009
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
It was reported that, during the routinely dressing changed for patients, a new iv3000 shaped 12x9cm ctn 50 was opened and the dressing was so adhesive that became a mass.Treatment was resumed, with a back-up device.Patient was not injured as consequence of this problem.It was confirmed that there was no delay.
Additional Manufacturer Narrative
H3, h6: 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 on the product family revealed no instances of this kind in the last three years.The instructions for use and risk files, mitigate similar instances to the reported issue with no updates required.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.It was reported that the dressing was so adhesive that it became a mass when opened.Probable root cause is incorrect storage of the device.Environmental factors such as temperature can alter the adhesive nature of the dressing which can make it more sticky.The device should be stored in the conditions outlined in the ifu to ensure it is in optimum condition for use.The users of the reported product are therefore 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 conditions in which the device should 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.
Additional Manufacturer Narrative
H3, h6: 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 on the product family revealed no instances of this kind in the last three years.The instructions for use and risk files, mitigate similar instances to the reported issue with no updates required.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.It was reported that the dressing was so adhesive that it became a mass when opened.Probable root cause is incorrect storage of the device.Environmental factors such as temperature can alter the adhesive nature of the dressing which can make it more sticky.The device should be stored in the conditions outlined in the ifu to ensure it is in optimum condition for use.The users of the reported product are therefore 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 conditions in which the device should 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 SHAPED 12X9CM 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; austin, TX 78735 ; 5123913905
• MDR Report Key: 12941588
• Report Number: 8043484-2021-01994
• Device Sequence Number: 14723864
• Product Code: KGX
• UDI-Device Identifier: 05000223455255
• UDI-Public: 05000223455255
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2022

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 Model Number: 66004009
• Device Catalogue Number: 66004009
• Device Lot Number: 2019
• 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: 11/16/2021
• Supplement Date Received by Manufacturer: 02/25/2022; 03/02/2022
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 02/28/2022; 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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