PERMANENT DUAL LUMEN CATHETER N/A PDLC-5512

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-06 for PERMANENT DUAL LUMEN CATHETER N/A PDLC-5512 manufactured by Vas Cath.

Event Text Entries

[18953089] A permanent dual catheter ws inserted on 10/17/90 for hemodialysis access. The device involves the placement of a cuff, which is incorporated into the subcutaneous tissue and anchors the cather into the subclavian vein. On 12/10/91 the catheter became dislodged from the subclavian vein. Upon surgical inspection, the cuff was found to be well incorporated into the subcutaneous tissue, and the cause of dislodgement was unknown. Device labeled for single use. Patient medical status prior to event: satisfactory condition. There was multiple patient involvement. Number of patients involved: 2. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: actual device involved in incident was evaluated, performance tests performed. Results of evaluation: material degradation/deterioration. Conclusion: device failure occurred and was related to event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device repaired and put back in service. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4024
• MDR Report Key: 4024
• Date Received: 1992-07-06
• Date of Report: 1992-01-09
• Date of Event: 1991-12-06
• Date Facility Aware: 1991-12-18
• Report Date: 1992-01-09
• Date Reported to Mfgr: 1992-01-09
• Date Added to Maude: 1993-05-12
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PERMANENT DUAL LUMEN CATHETER
• Generic Name: PERMANENT DUAL LUMEN DIALYSIS CATHETER
• Product Code: FGH
• Date Received: 1992-07-06
• Model Number: N/A
• Catalog Number: PDLC-5512
• Lot Number: 895-200
• ID Number: N/A
• Device Expiration Date: 1994-05-01
• Operator: OTHER CAREGIVERS
• Device Availability: N
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 3757
• Manufacturer: VAS CATH

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-07-06