DOUBLE LUMEN COOK CATHETER UNKNOWN CTPNS90D80CHEMO

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-31 for DOUBLE LUMEN COOK CATHETER UNKNOWN CTPNS90D80CHEMO manufactured by Cook, Inc..

Event Text Entries

[953] A double lumen cook catheter inserted in a 77 year old female patient on december 6, 1991. On march 30, 1992 when the attending physician attempted to removed the central line, the catheter broke. The patient was taken tote operating room for removal of the remaining piece. The catheter was not retained. The patient was discharged to a skilled nursing facility in stable conditiondevice labeled for single use. Patient medical status prior to event: satisfactory 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 not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device discarded, other. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3133
• MDR Report Key: 3133
• Date Received: 1992-07-31
• Date of Report: 1992-07-28
• Date of Event: 1992-03-30
• Date Facility Aware: 1992-03-30
• Report Date: 1992-07-28
• Date Reported to Mfgr: 1992-06-08
• Date Added to Maude: 1993-04-09
• 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: DOUBLE LUMEN COOK CATHETER
• Generic Name: N/A
• Product Code: FGH
• Date Received: 1992-07-31
• Model Number: UNKNOWN
• Catalog Number: CTPNS90D80CHEMO
• Lot Number: UNKNOWN
• ID Number: N/A
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 2922
• Manufacturer: COOK, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-07-31