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

Model Number MC101242

Device Problem Leak/Splash (1354)

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

Event Date 09/27/2019

Event Type  malfunction  

Manufacturer Narrative

The hemo-cath was returned for evaluation.The returned device leaks from both the venous and arterial extension.The device was forwarded to medcomp engineering.Medcomp engineering determined this to be a potential manufacturing issue.Supplier corrective action request was issued to the contract manufacturer for this incident.

Event Description

Upon accessing patient's line to initiate hemodialysis initially only arterial extension was noted to have a pin hole leak.When attempting to draw labs from venous extension, another pin hole found.

• Brand Name: 12.5FX18CM LT HEMO-CATH
• Type of Device: HEMO-CATH 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: 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 9410976
• MDR Text Key: 169114819
• Report Number: 2518902-2019-00073
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 88490802999
• UDI-Public: 88490802999
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113487
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: MC101242
• Device Catalogue Number: MC101242
• Device Lot Number: MMBF580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1