MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 8F X 12CM HEMO-CATH; HEMO-CATH ST HEMODIALYSIS CATHETER

Model Number	SL12P
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A pore appeared in the catheter extension.
Additional Manufacturer Narrative
We are currently waiting for the device to be returned for evaluation.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Multiple requests for the device to be returned for evaluation were not successful.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured, assembled, and inspected according to specification with no non-conformances or abnormalities.The manufacture process includes a 100% leak test performed as a last step in the process.This test would have detected any holes, leaks, or weak spots if they had existed at the time of manufacture.Without an evaluation of the device a root cause cannot be determined.The instructions for use (ifu) contains the following precautions: do not use sharp instruments near the extension lines or tubing.Do not use scissors to remove dressing.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
The complaint was received on november 3, 2021.Multiple requests for device return were not successful.The complaint was originally closed by medcomp on march 2, 2022.The 8f hemo-cath was returned for evaluation on april 5, 2022.Visual inspection confirms the complaint as a leak was noted on the venous extension approximately 1.5 cm from the hub.Under magnification the leak is the result of a small pin hole that appears to be a puncture.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured, assembled, and inspected according to specification with no non-conformances or abnormalities.The manufacture process includes a 100% leak test performed as a last step in the process.This test would have detected any holes, leaks, or weak spots if they had existed at the time of manufacture.While the complaint is confirmed a root cause cannot be determined.The instructions for use (ifu) contains the following precautions: do not use sharp instruments near the extension lines or tubing; do not use scissors to remove dressing.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 8F X 12CM HEMO-CATH
• Common Device Name: HEMO-CATH ST HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 12760498
• Report Number: 2518902-2021-00061
• Device Sequence Number: 14490951
• Product Code: MPB
• UDI-Device Identifier: 00884908045123
• UDI-Public: 884908045123
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/06/2022

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?: No
• Operator of Device: Other
• Device Expiration Date: 09/07/2024
• Device Model Number: SL12P
• Device Catalogue Number: SL12P
• Device Lot Number: MMCQ030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 11/03/2021; 11/03/2021
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 03/02/2022; 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Sex: Female
• Patient Weight: 20 KG