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

Model Number MC101243

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/28/2020

Event Type  malfunction  

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 Description

Catheter damage discovered in dialysis clinic.Unable to run dialysis due to "pinhole" in blue catheter, distal to patient.

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
• Type of Device: HEMO-CATH LT HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 10835826
• MDR Text Key: 216109425
• Report Number: 2518902-2020-00057
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908083002
• UDI-Public: 884908083002
• Combination Product (y/n): N
• PMA/PMN Number: K113487
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR
• Patient Weight: 34