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

Model Number	420645
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
(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, there was stain on the dressing (not on package).The product was not used by the patient.A photograph depicting the issue was received from the complainant.
Additional Manufacturer Narrative
Additional information - this emdr is being submitted to include the below: d9: device available for evaluation has been selected as yes & date returned to mfg was added as well.H3: device evaluated by mfg h6: investigation results under type of investigation, investigation findings, investigation conclusions h11: investigation summary a batch record review was completed and no discrepancies were found.All in-process stat sample quality checks were satisfactory.Aquacel foam ag n/adh 15x15(1x5) nai was manufactured under system application product (sap) code 1704021 and manufacturing lot number 4b01857 on 14 feb 2024.Lot # 4b01857 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 4b01857.This is the second of 3 complaints for this lot registered within database.The first complaint is for staining on dressing, and the other is questioning the batch artwork.However, neither are expected to be related to this, as although the first complaint is identifying a stain on the dressing (foreign matter), it is different from the staining identified in this complaint.2 photographs were received for this issue and have been evaluated in accordance with work instructions (wi).The photographs confirm the expected lot, product and the complaint issue where a stain or foreign matter can be seen, either on or beneath the pink pu of the dressing.The complaint sample was requested on 28 may 2024 and received on 20 june 2024.The complaint sample was received and sent to the lab for analysis to identify the foreign matter.The foreign matter was confirmed to be a mass of fibrous material found beneath the pink polyurethane film (pu) layer of the dressing.The fibrous material was confirmed as synthetic, observed to have a silver/grey, white and purple coloring.Further analysis of the matter confirmed it to be un-needled ag hydrofibre tow found between the pink polyurethane film (pu) and the foam layer of the dressing.At the time of the dressing production, it is possible that this tow was a white color, and not immediately observable.The grey coloring of the mass may have occurred over time and exposure to uv light.If the tow was visibly grey, it may not have been observed during inspection, or may have been mistaken for a part of the artwork symbiology on the external surface of the polyurethane film (pu) layer.It is not certain how un-needled ag tow may have entered this part of the process as the tow is processed on textile lines to produce the intermediate hydrofibre fabric used in the foam dressing.It is most likely this tow has adhered to the unwinding pink polyurethane film (pu) during the manufacture of the cut dressings and missed during later inspection.2 complaints for foreign matter have been received for this batch, totaling 2 affected dressings.With the batch size of 9600 dressings, this would be an acceptable failure rate based on the acceptable quality level (aql) from process instruction (pi), with an accept 2 and reject 3 based upon a sample of 200 dressings.As only 894 packs remain in dcs, it is likely over 200 dressings have been exhausted, and as 2 dressings have confirmed foreign matter, it remains below acceptable quality level (aql), so no corrective and preventive actions (capa) is necessary.As this matter is confirmed as ag hydrofibre tow, it has originated from an intermediate manufacturing process and is therefore not of risk to the patient.A recent increase in foreign matter complaints resulted in corrective and preventive actions (capa)1888590 being opened to investigate 7 other complaints for foreign matter and are confirmed as unrelated to this complaint.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.
Event or Problem Description
To date no additional patient or event details have been received.

• 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: 19544664
• Report Number: 1000317571-2024-00045
• Device Sequence Number: 7606432
• Product Code: FRO
• UDI-Device Identifier: 00768455123896
• UDI-Public: 00768455123896
• 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): 05/23/2024

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 Model Number: 420645
• Device Lot Number: 4B01857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 06/16/2024
• Supplement Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2024
• 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