MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 12.5FX18CM LT HEMO-CATH; HEMO-CATH LT HEMODIALYSIS CATHETER

Model Number	MC101242
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	11/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated.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.
Event or Problem Description
During the haemodialysis session was observed a semicircular cut on the arterial branch of the catheter.Report indicated the patient lost 20-100cc of blood.The catheter was changed.
Additional Manufacturer Narrative
The hemo-cath was returned for evaluation.Visual inspection confirmed the complaint.When the arterial side is flushed a leak is detected at the connection of the extension line and the luer.A tear is visible on the extension line at the end of the luer.When viewed under magnification the tear appears smooth and straight which is consistent with being cut with a sharp object.The contract manufacturer conducted a review of the manufacture records for the lot number reported.The review showed the device was manufactured and inspected according to specification.The process includes a 100% leak test of the device at the end of the manufacture process.This test would have detected the leak if it had occurred during the manufacture process.The device was implanted for 1 year and 10 months prior to the event.A definitive root cause cannot be determined but is deemed not related to the manufacture process.The instructions for use (ifu) contains the following precautions: do not use sharp instruments near the extension tubing or catheter lumen.Do not use scissors to remove dressing.Device was used for treatment, not diagnosis.

• Brand Name: 12.5FX18CM LT HEMO-CATH
• Common Device Name: HEMO-CATH LT HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 10937130
• Report Number: 2518902-2020-00060
• Device Sequence Number: 3019388
• Product Code: MSD
• UDI-Device Identifier: 00884908082999
• UDI-Public: 884908082999
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: K113487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2021

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: 06/30/2022
• Device Model Number: MC101242
• Device Catalogue Number: MC101242
• Device Lot Number: MKBV120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 8 YR
• Patient Weight: 26