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

Model Number	66024008
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
Event or Problem Description
It was reported that, the patient came to the hospital for picc catheter maintenance due to lung malignant tumor.The nurse found that there was one 4cm length white hair located on the inner side of the iv3000 1 hand 10x12cm until the dressing was applied to the patient.The treatment continued with a smith a nephew back up.The patient was not harmed.
Additional Manufacturer Narrative
It was reported that the patient came to the hospital for picc catheter maintenance due to lung malignant tumor.The nurse found that there was one 4cm length white hair located on the inner side of the iv3000 1 hand 10x12cm this was not noticed until the dressing was being applied to the patient.The treatment continued with a smith a nephew back up.The patient was not harmed.The device was used for treatment and was not returned for analysis.No photographs were provided in support of this complaint.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 no similar instances in the last three years.A risk management review concluded that without further information the alleged failure mode can not be directly linked to a specific failure mode within the risk file although it does contain several failure modes that can result in contamination.As the dressing has been confirmed as a new dressing and it is further stated in the complaint that the contamination was not noticed until the dressing was being placed on the patient, the most probable root cause is that the contamination occurred as the dressing was being applied to the patient when the backing paper was removed.Production staff working on the manufacture of the product follow strict protocol in relation to dress and have all hair covered to prevent any contamination of this kind.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 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: 13865636
• Report Number: 8043484-2022-00108
• Device Sequence Number: 14619241
• Product Code: KGX
• UDI-Device Identifier: 05000223417406
• UDI-Public: 05000223417406
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2022

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: 66024008
• Device Catalogue Number: 4008
• Device Lot Number: 2032
• 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: 03/01/2022
• Supplement Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 05/10/2022
• 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 Age: 67 YR
• Patient Sex: Male