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

Model Number	420642
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
Additional Manufacturer Narrative
E1: complainant street address: (b)(6).Complainant city: (b)(6).Complainant state: (b)(6).Complainant postal code: (b)(6).Complainant country: philippines.Name of affiliation: (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
The distributor reported that a foreign matter was found on dressing.The product was not used by the patient.Photographs depicting the issue were received from the complainant.
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 imdrf cause investigation code, imdrf investigation findings, imdrf cause conclusions.H10: investigation summary.A batch record review was completed, and no discrepancies were found.All in-process stat sample quality checks were satisfactory.Affected amount: 1 device.Aquacel foam ag n/adh10x10(1x10) nai was manufactured under system application product (sap) code 1704015 and manufacturing lot number 3e00646 on 05 may 2023.Lot # 3e00646 was sterilized under work order 3341660 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 3e00646.This is the only complaint for the affected lot registered within database.Two photographs were received for this issue and has been evaluated in accordance with work instructions (wi).The photographs confirm the expected lot, product, and the complaint issue where foreign matter in the form of a dark, thin curl is seen on the edge of the printed pink polyurethane (pu) of the dressing.The complaint sample was requested on 03 november 2023 and received on 22 jan 2024.The complaint sample was received and sent to the lab for fourier transform infrared spectroscopy (ftir) analysis to identify the foreign matter.The foreign matter appeared to look like a curl of dark but translucent plastic material.As fourier transform infrared spectroscopy (ftir) analysis will not identify where the plastic could have come from, two other samples of plastic were analyzed to compare with the complaint sample.A sample of foam line black bin bag and a sample of reel core burr were analyzed for comparison, and the fourier transform infrared spectroscopy (ftir) spectrum indicated more similarities between the complaint sample and the sample of reel core burr material.The black bin bag was not comparable, making it more likely that the foreign matter was a small shaving of reel core burr.The grey reel cores that were used to yield a comparable sample are used for on-wind of waste materials from the dressing assembly, and while some of the cores are held above the product assembly line, the dressings are collated and individually flipped and assembled on a conveyor by hand, so it is likely that any burr that has fallen onto the dressings during the assembly and cutting process would have been removed with handling of the dressings.The burr was also found on the printed pink polyurethane (pu) side of the dressing (non-wound contact).The dressings are inspected by operators, but as the foreign matter is a similar color and shape to the grey ag branding printed onto the dressings, this foreign matter in particular would have been difficult to spot by human inspection at validated line speeds.There is an expectation that some defects may not be effectively identified.The acceptable quality levels (aqls) listed in process instruction (pi) for manufactured product identifies a batch of this size could have five dressings accepted, six rejected for contamination.As no other complaint have been received, this issue remains below acceptable quality levels (aqls) for this type of failure, so no corrective action / preventive actions (capa) is necessary to investigate.Reel cores in the production area used for the waste are cleaned before use, and twelve examples inspected from the clean room had no loose burr.No further actions are required at this time.This issue will be monitored through the post market product monitoring review process.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 ; 3365424679
• MDR Report Key: 18370678
• Report Number: 1000317571-2023-00325
• Device Sequence Number: 7767556
• Product Code: FRO
• UDI-Device Identifier: 00768455123889
• UDI-Public: 00768455123889
• 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): 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
• Operator of Device: Other
• Device Expiration Date: 05/01/2026
• Device Model Number: 420642
• Device Lot Number: 3E00646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2023
• 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