MAUDE Adverse Event Report: CONVATEC LTD L3W0900 - AQUACEL AG; DRESSING, WOUND, DRUG

Model Number	420681
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Contamination /Decontamination Problem (2895); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the nurse found black spots on the dressing which should not have been there.This was observed on 5 boxes (50 dressings) and all boxes that had been taken by the sales representative who involved in case want to be analyzed.The product was not used.A photograph depicting the issue was received from the complainant.
Additional Manufacturer Narrative
Device 46 of 50.Complainant street address: (b)(6), complainant city: (b)(6), complainant state/province: (b)(6), complainant postal code: (b)(6), complainant country: spain, health care center: (b)(6), health care professionals: (b)(6).Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Additional information - this emdr is being submitted to include the below: d4: unique identifier (udi) #.H6: investigation results under imdrf cause investigation code, imdrf investigation findings, imdrf cause conclusions.H10: investigation summary.A batch record review was completed, and no discrepancies were found.Aquacel foam ag adh 10x10cm 1x10pk eur was manufactured under system application product (sap) (b)(4) and manufacturing lot number 2c03688 on 27th march 2022.Lot # 2c03688 was sterilized under order (b)(4) and released on review of results of sterilization provided by sterilization company sterigenics.All the results were within specification and products were released.No nonconformity was identified during the manufacturing process of lot 2c03688.This is the only complaint for the affected lot registered within database.One photograph was received for this issue and has been evaluated in accordance with work instruction (wi).The photograph does not confirm the expected lot number, but the product shown appears to be an example of the affected product.The complaint issue is confirmed.There are two dark yellow-brown diffused spots on the dressing pad at the point of intersection of the silicone border and the release liner fold.The samples under complaint were requested for investigation.A nonconformance record was opened for a previous complaint received with an identical failure mode.The non-conformance was originally opened, but no sample was returned, so a root cause investigation into the issue was not possible.An additional complaint was received for the same failure mode, also included within the nonconformance record.Samples of complaint dressings were available, requested and were received at the deeside manufacturing site on 02 august 2022.An investigation was raised to investigate the sample dressings and the brown spots were identified to be made up of hydrocarbon contamination.All oils and lubricants used on the circle manufacturing line is silicone based, indicating that the contamination on the dressings did not originate from the circle line.The contamination appears to be associated with the kiss cutter on the line, and contamination of this kind could only have originated from the kiss cutter maintenance regime whereby the kiss cutter blade is redressed.The contamination is likely to have entered the process at this point.The tools are lubricated after repair/regrind by a third party to enhance corrosion resistance, the tools are cleaned down prior to use by the tooling technician where an alternate lubricant is applied to the journals and the gears.All lubricants used at deeside are approved for use in manufacture of food, medical device and pharmaceutical sectors.Recommendation is to update the change-over procedure to include a specific cleaning step of the tooling dies prior to installation on the equipment.This issue will be monitored through the post market product monitoring review process, standard operating procedure (sop).To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 1049092, manufacturing site: 1000317571.

• Brand Name: L3W0900 - AQUACEL AG
• Common Device Name: DRESSING, WOUND, DRUG
• Manufacturer (Section D): CONVATEC LTD; first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• Manufacturer (Section G): CONVATEC; 7815 national service road; suite 600; greensboro NC 27409
• Manufacturer Contact: pamela meadows ; suite 400; 7900 triad center drive; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 15248124
• Report Number: 1000317571-2022-00209
• Device Sequence Number: 5847964
• Product Code: FRO
• UDI-Device Identifier: 00768455127153
• UDI-Public: 00768455127153
• Combination Product (Y/N): N
• PMA/510(K) Number: K123481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2022

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: 03/01/2024
• Device Model Number: 420681
• Device Catalogue Number: 420681
• Device Lot Number: 2C03688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2022
• Supplement Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown