MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 10F X 24CM HEMO-CATH SILICONE; HEMO-CATH LT HEMODIALYSIS CATHETER

Model Number	MC101045P
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our investigation is ongoing.A follow up report will be submitted when the investigation is complete.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.
Event or Problem Description
During dialysis catheter was not functioning and a leak was noted.After removal a leak was noted proximal to the cuff.
Additional Manufacturer Narrative
The device involved in the incident was not returned for evaluation.A video was provided that shows a lumen leak that appears to be just proximal to the cuff.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured and inspected according to specification with no non-conformances or abnormalities.The manufacturing process includes a 100% leak test performed as a last step in the process.This test would have detected any leaks, holes, or weak spots if it 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 warning: do not use sharp instruments near the extension tubing or catheter lumen.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: 10F X 24CM HEMO-CATH SILICONE
• Common Device Name: HEMO-CATH LT 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: 17180903
• Report Number: 2518902-2023-00047
• Device Sequence Number: 12398734
• Product Code: MSD
• UDI-Device Identifier: 00884908093308
• UDI-Public: 00884908093308
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 01/05/2025
• Device Model Number: MC101045P
• Device Catalogue Number: MC101045P
• Device Lot Number: MQFC860
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 7 YR
• Patient Sex: Male
• Patient Weight: 28 KG