MAUDE Adverse Event Report: CONVATEC LTD L3W0250 - KALTOSTAT; DRESSING,WOUND,HYDROPHILIC

Model Number	168212
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant state/province: (b)(6).Complainant country: (b)(6).Dealer: (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).Manufacturing site: (b)(4).
Event or Problem Description
It was reported that primary package was sealed with product.The device was not used by end user.A 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.A batch record review was completed and no discrepancies were found.Kaltostat drs 7.5x12cm (1x10pk) ster jp was manufactured under system application product (sap) code 1021632 and manufacturing lot number 1g02913 on 01 september 2021.Lot 1g02913 was sterilised under lot 2173-22081a and released on review of results of sterilisation provided by sterilisation company steris.All of the results were within specification and products were released.No nonconformity was identified during the manufacturing process of lot 1g02913.This is the second complaint for the affected lot registered within database, the other complaint being for ¿dressing messed in package¿.One photograph was received for this issue and has been evaluated in accordance with per work instructions (wi).The photograph confirms the expected lot number, product and the complaint issue where the dressing in seal is evident.A nonconformance was opened for this complaint issue.A data review was raised, but as other complaints and non-conformances had been raised for similar failures on doyen 2, an older investigation was still relevant for this issue and failure mode.This investigation, completed in september 2021, identified a poor nip roller drive causing material positioning issues, and not detected due to a cross scene illumination variance.As the affected batch was manufactured 01 july 2021, the batch is within the investigation bounding dates.Improvements to the line are being made under an open corrective and preventive actions (capa).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: L3W0250 - KALTOSTAT
• 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: 15181887
• Report Number: 1000317571-2022-00140
• Device Sequence Number: 12238687
• Product Code: NAC
• UDI-Device Identifier: 00768455122790
• UDI-Public: 00768455122790
• 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): 07/13/2022

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: 07/01/2024
• Device Model Number: 168212
• Device Catalogue Number: 168212
• Device Lot Number: 1G02913
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2022
• Supplement Date Received by Manufacturer: 09/15/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 10/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2021
• 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