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

Model Number	421927
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
Additional Manufacturer Narrative
Common device name - dressing wound occlusive.Reporter information: (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
It was reported that there was foreign matter black dot/strip inside the primary package.The product was not used on patient.The photographs depicting the issue were received from the complainant.
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.Convatec foam lite 5x5cm 1x10 ster eur was manufactured under system application product (sap) code 1719849 and manufacturing lot number 2c02617 on 18 march 2022.Lot # 2c02617 was sterilized under reference order 3004020 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 2c02617.These one of three complaints received against lot 2c02617.Two other complaints have been received for empty primary sachets.2 photographs were received for this issue and has been evaluated in accordance with work instruction (wi).The photograph confirms the expected product and the complaint issue where foreign matter can be seen on the dressing pad.The sample for the complaint was requested on 20th september 2022 and received on 3rd october 2022.An nc (nonconformity) was opened for this issue for foreign matter on the dressing.Upon receiving the complaint sample, the sample was sent for laboratory analysis to confirm chemical identity for investigation to begin.Due to the location of the foreign matter on the dressing, investigation is limited to a single few areas on the manufacturing equipment where the dressing pad is exposed during manufacture to allow for possible contamination with the foreign matter.There is also the possibility this contamination could have come from a supplier on the material.The foreign matter was identified as a piece of non-stainless but allowed, non-magnetic carton steel, used in low value machine elements such as sprints, bolts and washers, cast housing or structural steel work.The foreign matter was likely already rusty at the point of contaminating the dressing.The most likely cause of the debris from the machine caused during routine operation at axis 7, but debris at axis 7 was found to be of different composition to the complaint sample.A corrective/preventative action (capa) was opened to address the issues identified during the investigation, including development of a robust cleaning regime, updates to process instructions and proposal to control restriction of carbon steel components.The investigation has been approved and is completed.No additional action is required, and this complaint will be closed.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 FOAM
• Common Device Name: DRESSING, WOUND, HYDROPHILIC
• 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: 15585618
• Report Number: 1000317571-2022-00327
• Device Sequence Number: 2810168
• Product Code: NAC
• UDI-Device Identifier: 00768455151189
• UDI-Public: 00768455151189
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• 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): 09/16/2022

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: Other
• Device Expiration Date: 03/01/2024
• Device Model Number: 421927
• Device Catalogue Number: 421927
• Device Lot Number: 2C02617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2022
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2022
• Supplement Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2022
• 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