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

Model Number	168117
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
Event or Problem Description
It was reported that a black thread like foreign matter was mixed in the product.Based on the photo, it looked like lint instead of hair.The product was not used by the patient.A photograph associated with the issue was received from the complainant.
Additional Manufacturer Narrative
Complainant state/province: (b)(4).Event country: japan.Name of affiliation: (b)(4).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
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: d9: device available for evaluation has been selected as yes & date returned to mfg was added as well.H3: device evaluated by mfg has been selected as yes.H6: investigation results under imdrf cause investigation code, imdrf investigation findings, imdrf cause conclusions h10: investigation summary batch record review results: a batch record review was completed, and no discrepancies were found.All in-process stat sample quality checks were satisfactory.Kaltostat wnd pkg 2g wt (1x5pk) ster int was manufactured under sap code 1703037 and manufacturing lot number 2c00999 on 08 march 2022.Lot # 2c00999 was sterilized under reference id (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 2c00999.This was the second complaint for the affected lot registered within database, the other complaint was being for wet marks on labelling.Upon receiving the complaint on 13 dec 2022, no photographs were received for this issue so could not be evaluated in accordance with work instruction (wi).As no photographs were provided, it was not possible to confirm the complaint.On 06 jan 2023, a single photo was provided for the complaint issue.This was evaluated in accordance with work instruction (wi).The image shows the expected lot number, product, and complaint issue where a piece of black thread-like foreign matter can be seen in the middle of the dressing.The sample was requested on 23 jan 2023 and was received on 30 jan 2023.The sample was analyzed with fourier transform infrared (ftir) to identify a poly-based material.A nonconformity (nc) was raised and due to the fact he thread was found interlaced with the kaltostat fibres and in the center of a folded ribbon product, it was most likely for this thread to have entered the process at rhymney.A number of potential garments were tested in an effort to find a match for the thread material found.Correlation was found between the fourier transform infrared (ftir) trace of the contaminant found in the complaint sample and of a thread from a convatec fleece.The trace was a match for fleece in general, so could be a fleece produced by any company.Investigation at both the rhymney and deeside sites were completed to identify how this thread could have entered the manufacturing process.No root cause could be identified at rhymney for how this thread could have entered the process, and investigation at deeside as part of corrective and preventive action (capa).The investigation at deeside was could also not identify a root cause for how the thread has contaminated a dressing.There was no evidence that this thread has entered the process at the deeside site.This issue will be monitored through the post market product monitoring review process.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: 16111154
• Report Number: 1000317571-2023-00014
• Device Sequence Number: 17852229
• Product Code: NAC
• UDI-Device Identifier: 00768455122776
• UDI-Public: 00768455122776
• 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): 12/13/2022

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: 09/01/2024
• Device Model Number: 168117
• Device Lot Number: 2C00999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2022
• Supplement Date Received by Manufacturer: 07/04/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2022
• 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