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

Model Number	420805
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The distributor reported that there was product discoloration (stain) on dressing.It was unknown whether the product was used on patient or not.The photographs depicting the issue were received from the complainant.
Additional Manufacturer Narrative
(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.Fda registration number reporting site: 1049092 manufacturing site: 1000317571.
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: h6: investigation results under type of investigation, investigation findings, investigation conclusions.H11: investigation summary: a batch record review was completed and no discrepancies were identified.Batch record revision results: aquacel foam ag adh 8x8cm 1x10 nai was manufactured under system application product (sap) code 1707747 and manufacturing lot number 3f00050 on 04 june 2023.System application product (sap) identifies manufacture date as 05 june 2023, but the batch record confirms manufacturing began at 7pm on 04 june 2023.Lot 3f00050 was sterilized under work order (b)(4) and released on review of results of sterilization provided by sterilization company sterigenics.All of the results were within specification and products were released.No nonconformity was identified during the manufacturing process of lot 3f00050.This is the only complaint for the affected lot registered within database.Two photographs were received for this issue and have been evaluated in accordance with work instruction (wi).The photographs confirm the expected lot number, the expected product and the complaint issue, where brown diffused spots of discoloration can be seen on the pad of the dressings.The complaint samples were requested on 07 may 2024, and received on 24 may 2024.A nonconformance database and later corrective action / preventive actions (capa) was opened as a result of several previous complaints identifying this failure mode within database received from (b)(6) 2022 onwards.The non-conformance was originally opened, but no sample was returned, so a root cause investigation into the issue was not possible.Upon receipt of later complaints with sample dressings available, laboratory testing confirmed the foreign matter as hydrocarbon contamination.Laboratory testing was complete for the complaint samples associated with this database, and confirmed by fourier transform infrared spectroscopy (ftir) analysis that the contamination on these newly received dressings has no distinct difference from previously received samples.This confirms the same contamination on the dressing.Additionally, as part of this complaint investigation, the delta 1 and delta 2 manufacture lines the dressings family is manufactured on were observed to have rgb sensors which emit a form of weak ultraviolet (uv) light.A line trial identified that the ultraviolet (uv) light emitted from the sensors could cause discoloration of the silverised hydrofibre.As the rgb sensors were not fully functional and were not associated with a rejection system, the sensors were removed from the lines to prevent any further discolorations of dressings that may have been caused by the ultraviolet (uv) emitted light.It is expected further complaints may be received for this which will be assessed in a similar manner.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: AQUACEL AG FOAM
• 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 LTD; first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 19391785
• Report Number: 1000317571-2024-00041
• Device Sequence Number: 20783517
• Product Code: FRO
• UDI-Device Identifier: 00768455129126
• UDI-Public: 00768455129126
• Combination Product (Y/N): N
• PMA/510(K) Number: K123481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2024

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: Other
• Device Expiration Date: 06/01/2026
• Device Model Number: 420805
• Device Lot Number: 3F00050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2024
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 07/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2024
• 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