MAUDE Adverse Event Report: CONVATEC LTD DUODERM PASTE AND GELS; NOT APPLICABLE

Model Number	187987
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Contamination /Decontamination Problem (2895); Device Contaminated During Manufacture or Shipping (2969); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter name and address: complainant city: (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: (b)(4).
Event or Problem Description
It was reported that the gel tube had a stain and bumps on the aluminum tube.The product was not used on patient.The photograph depicting the issue was received from 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.H6: imdrf investigation findings has been selected as c22 for term "improper printing while labelling process".A batch record review was completed and no discrepancies were found.Duoderm h/active gel (3tbex30g) ster us was manufactured under sap code (b)(4) and manufacturing lot number 2a02568 on 07 feb 2022.Lot # 2a02568 was sterilised under reference 22a10k7774 and 22a10k7772 and released on review of results of sterilisation provided by sterilisation company baxter.All of the results were within specification and products were released, with the exception of box fifty-seven which was destroyed due to the product potentially not receiving the correct sterilisation dose.No nonconformity was identified during the manufacturing process of lot 2a02568, but a nonconformity was raised following sterilisation for an unrelated matter.There were two complaints against lot 2a02568, including this complaint.The additional complaint is related to this complaint and covers the damage aspect of the complaint received.One photograph was received for this issue and has been evaluated in accordance with work instructions (wis).The photographs confirm the expected lot number, product and the complaint issue.The image showed three tubes with red rings marking ¿staining¿, where black printed labelling is shown to be offset over the tube labelling and dented, and what appeared to be a slight chip in the paint of the primary tube.The other red rings appear to be marking tube damage.It was not possible to have the sample returned due to courier restrictions in the latam (latin america) region for the product.A previous nonconformance was opened for this a gel batch under a similar complaint for staining on the primary pack.Triage identified that the photographs received showed the tube to have printed information not applied at the manufacturing site.Latam (latin america) regulatory representatives confirmed this relabelling activity was completed in caribetrans latam (latin america) warehouses due to local requirements using an inkjet printer.The offset in the printing in this complaint will be a print defect from the caribetrans relabelling process for the latam (latin america) region.The supplier has been made aware.The defect circled red on the photograph appeared to be a slight indent, not allowable by the standards of acceptability, but it is not clear if this is a defect from the supplier, damage sustained during transit or damage sustained during the relabelling process for the latam region.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: DUODERM PASTE AND GELS
• Common Device Name: NOT APPLICABLE
• 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: 15742266
• Report Number: 1000317571-2022-00335
• Device Sequence Number: 12177587
• Product Code: NAE
• UDI-Device Identifier: 00768455172979
• UDI-Public: 00768455172979
• 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): 10/13/2022

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: 01/01/2025
• Device Model Number: 187987
• Device Catalogue Number: 187987
• Device Lot Number: 2A02568
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2022
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2022
• 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