MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 16F X 32CM SPLIT CATH III CATHETER SET; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number DASPC3216-3

Device Problems Material Fragmentation (1261); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2022

Event Type  malfunction  

Event Description

Mds placing permcath, the catheter snaps/breaks open after placement but the catheter pieces crumbled into pieces, md checked over all of the pieces, asked for documentation and we placed pieces in container labelled w/pt name and implant sticker.The permcath was inserted into the introducer sheath and advanced.As the catheter was advanced, the sheath was split and divided, removing the sheath as the catheter was advanced into place.Fluoroscopy was again brought on to the field and the catheter position was examined.The entire course of the catheter was then viewed, and it was found to be in adequate position without evidence of kinking through the subcutaneous tunnel.The flow through both lumens was checked with a syringe, and found to be excellent.

• Brand Name: 16F X 32CM SPLIT CATH III CATHETER SET
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 15592603
• MDR Text Key: 301735431
• Report Number: 15592603
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DASPC3216-3
• Device Catalogue Number: DASPC3216-3
• Device Lot Number: MQFL150
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/26/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1