N/I

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-01-18 for N/I manufactured by Unknown.

Event Text Entries

[1732] This case involves a patient admitted for a presumed right subclavian hemodialysis line sepsis. The patient went to the o. R. For a peritoneal tenkoff catheter placement. During the proceudre a previously inserted tenkoff catheter portion was removed. Please note it appears the retreival tenkoff catheter had been placed in the patient an undetermined amount of years prior to this date. The patient tolerated the procedure. He was discharged home ten days laterdevice labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. 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. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, other. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: unknown (cannot determine). Corrective actions: other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2320
• MDR Report Key: 2320
• Date Received: 1993-01-18
• Date of Report: 1992-12-31
• Date of Event: 1992-12-11
• Date Facility Aware: 1992-12-11
• Report Date: 1992-12-31
• Date Reported to FDA: 1992-12-31
• Date Added to Maude: 1993-02-04
• 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

• Generic Name: TENKOFF PERITONEAL DIALYSIS CATHETER
• Product Code: FKO
• Date Received: 1993-01-18
• Model Number: N/I
• Catalog Number: N/I
• Lot Number: N/I
• ID Number: N/I
• Device Availability: Y
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 2146
• Manufacturer: UNKNOWN

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-01-18