MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 12.5FX24CM HEMO-CATH; HEMO-CATH LT HEMODIALYSIS CATHETER

Model Number	MC101243
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
Catheter damage discovered in dialysis clinic.Unable to run dialysis due to "pinhole" in blue catheter, distal to patient.
Additional Manufacturer Narrative
The hemo-cath was returned for evaluation.Visual inspection confirms the complaint as there is a small leak on the venous extension.Inspection under magnification shows the hole is semi-circular which is consistent with the beveled end of a needle.A review of the manufacture records for the lot number reported was conducted by the contract manufacturer.Their review revealed the device was manufactured according to specification with no non-conformances or abnormalities.The process includes a 100% leak test that would have detected a leak in the extension.The device was implanted for more than six weeks prior to the incident.A definitive root cause cannot be determined but is most likely not manufacture related.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: 12.5FX24CM 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: 10835826
• Report Number: 2518902-2020-00057
• Device Sequence Number: 2904424
• Product Code: MSD
• UDI-Device Identifier: 00884908083002
• UDI-Public: 884908083002
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K113487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2020

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: 04/21/2025
• Device Model Number: MC101243
• Device Catalogue Number: MC101243
• Device Lot Number: MPAB300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 12/10/2020
• 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: 11 YR
• Patient Weight: 34