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

Model Number	168210
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
Complainant state/province: shizuoka.Complainant country: japan.Name of dealer: kyowa-ikakikai.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: (b)(4).
Event or Problem Description
It was reported that there was foreign matter inside primary package and it was opened by customer.The 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.Kaltostat drs 5x5cm (1x10pk) ster jp was manufactured under system application product (sap) 1021624 and lot number 1k03233 manufactured on 08 november 2021.Lot # 1k03233 was sterilised under lot 2173-24152a and released on review of results of sterilisation provided by sterilisation company steris.All results were within specification and products were released.No nonconformity was registered during the manufacturing process of lot 1k03233.This is the only complaint for the affected lot registered within database.One photograph and the original sample were received for this issue and have been evaluated in accordance with work instructions (wis).The photograph confirmed the expected lot number product and complaint issue.The original sample was requested for chemical identification of the contaminant/foreign matter.The sample was requested on 06 sept 2022 and received on 13 sept 2022.A non-conformance record was raised, and an investigation completed to identify the foreign matter.As the sample was returned from the customer, investigation confirmed the foreign matter was consistent with a polypropylene based material.Further investigation confirmed that the foreign matter has originated from the polypropylene cores used for kaltostat reelstock.The root cause is identified as human error due to the cores not being manually deburred to result in the foreign matter reaching the final product pack.A procedure is in place for the deburring of cores, and retraining has been completed for operators.This issue will be monitored through the post market product monitoring review process, standard operating procedures (sops).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: 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: 15454028
• Report Number: 1000317571-2022-00223
• Device Sequence Number: 6864698
• Product Code: NAC
• UDI-Device Identifier: 00768455122783
• UDI-Public: 00768455122783
• 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): 08/26/2022

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: Lay User/Patient
• Device Expiration Date: 02/01/2024
• Device Model Number: 168210
• Device Catalogue Number: 168210
• Device Lot Number: 1K03233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2022
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/26/2022
• Supplement Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 09/20/2022
• Supplement Report FDA Received Date: 12/23/2022
• Date Device Manufactured: 11/08/2021
• 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