MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE FLEXIFIX 5CMX10M CTN 1; TAPE AND BANDAGE, ADHESIVE

Catalog Number	66000040
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during set up for treatment, when one (1) opsite flexifix 5cmx10m ctn 1 was taken out of the carton, it was confirmed there were a lot of holes in line on the film.Treatment was resumed, without any delay, using a s+n back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
Internal reference case-(b)(4).
Additional Manufacturer Narrative
It was reported that, during set up for treatment, when one (1) opsite flexifix 5cmx10m ctn 1 was taken out of the carton, it was confirmed there were a lot of holes in line on the film.Treatment was resumed, without any delay, using a s+n back-up device.Patient was not injured as consequence of this problem.The sample has not been returned for evaluation, therefore we cannot establish a relationship between the product and the reported event, or identify a definitive root cause.The probable cause remains unknown.Factors may include.Human error during the manufacturing process.The line on which these dressings are produced will stop in the event that a quality issue is identified, at which point the line should be cleared of any potentially affected dressings.It is possible that the reported holes in the dressings has been missed by the operator during this line clearance and subsequently packaged along with unaffected good dressings.Strict quality checks remain in place to minimise the likelihood of re-occurrence(s) of this issue.A complaint history review revealed a number of similar instances in the last 12 months.There is nothing to indicate this is outside of acceptable rates of occurrence.The manufacturing records show no contributory factors relating to the reported event, confirming that the device was released according to the final product specification, with no non-conformances or deviations associated with this lot.No further actions by smith & nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith & nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: OPSITE FLEXIFIX 5CMX10M CTN 1
• 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: 17667614
• Report Number: 8043484-2023-00056
• Device Sequence Number: 15034049
• Product Code: KGX
• UDI-Device Identifier: 05000223411466
• UDI-Public: 5000223411466
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2023

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
• Device Expiration Date: 04/01/2025
• Device Catalogue Number: 66000040
• Device Lot Number: 2217
• 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: 08/29/2023
• Supplement Date Received by Manufacturer: 11/24/2023
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown