COOK CATHETER 7FR N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-02-13 for COOK CATHETER 7FR N/A manufactured by Cook Incorporated.

Event Text Entries

[1554] On 9/27/92 it was reported that the patient cook catheter @ a small hole just above the y lumen. Arrangement to hose the catheter repaired were in the process. When on 9/28/92 the patient returned to the unit & the y lumen of the catheter was missing. Patient was transferred to westchester county medical center as imitally, it was thought the catheter would have to be surgically replaced. Wcmc was able to repair the catheter without surgery & she was returned to the hospital when the broken lumen was returned, it was discovered that the catheter had been repaired once before @ the same sitedevice not 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: visual examination. Results of evaluation: telemetry failure, y-piece connector, tubing. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device repaired and put back in service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3924
• MDR Report Key: 3924
• Date Received: 1993-02-13
• Date of Event: 1992-09-28
• Date Facility Aware: 1992-09-28
• Date Added to Maude: 1993-05-10
• 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: COOK CATHETER 7FR
• Product Code: GBP
• Date Received: 1993-02-13
• Model Number: N/A
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: N/A
• Device Availability: Y
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 3663
• Manufacturer: COOK INCORPORATED

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. No Informationnvalid Deathata	1993-02-13