MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC.; CATHETER, HEMODIALYSIS

Lot Number MPZP450S2

Device Problems Material Puncture/Hole (1504); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 10/12/2022

Event Type  malfunction  

Event Description

Upon routine assessment of the patient for dialysis, spots of frank blood noted on patient's shirt.Further inspection of the catheter revealed a pin hole defect on the arterial port of the hemodialysis catheter.

• Type of Device: CATHETER, HEMODIALYSIS
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 16213973
• MDR Text Key: 307780210
• Report Number: 16213973
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/30/2022,12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: MPZP450S2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/30/2022
• Device Age: 3 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/20/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 4015 DA
• Patient Sex: Male
• Patient Weight: 23 KG
• Patient Ethnicity: Hispanic