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

Catalog Number	4630
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during set up or inspection for treatment, the individual pouch of one (1) opsite flexigrid 10x12cm ctn 50 was not sealed.The treatment was resumed, without any delay, using a s+n back-up device.Since incident occurred before procedure; patient was not yet involved.
Additional Manufacturer Narrative
H10.Internal reference number: (b)(4).
Additional Manufacturer Narrative
H3, h6: given the nature of the alleged incident, the product, could not be returned for evaluation; therefore, product analysis could not be performed.Device batch number was not provided; thus, an evaluation of the manufacturing records could not be performed.No similar events were found in the complaint history; therefore, this would suggest it is an isolated event.Additionally, there have been no previous investigations for the part number and failure mode reported.According to the flexigrid dressings on the high-speed films line specification, the dressing passes through an in-process seal integrity testing.The document includes all the specifications that must be followed during the sealing process.The risk management documentation for opsite flexigrid has been reviewed to assess whether the alleged failure and associated harm has been anticipated.A review of the most recent complaint data for opsite flexigrid confirmed no further occurrences of pouch seal failures, equating to a probability rating of improbable and therefore considered as acceptable with no impact to the risk file ratings.Probable causes include that the pouches experienced unexpected high pressure after shipment and the air inside pouches burst the pouch seals open or a failed in-process inspection during manufacturing.No manufacturing, packaging, labelling, design, concerns nor adverse trend have been observed; therefore, no corrective actions are deemed necessary.

• Brand Name: OPSITE FLEXIGRID 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: 20025039
• Report Number: 8043484-2024-00082
• Device Sequence Number: 8566576
• Product Code: KGX
• UDI-Device Identifier: 05000223415419
• UDI-Public: 05000223415419
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 10/25/2024

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 Catalogue Number: 4630
• Device Lot Number: UNKNOWN
• 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: 07/21/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/25/2024
• 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 Age: 60 YR
• Patient Sex: Male