NEEDLE N/A CNP-15

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-11-20 for NEEDLE N/A CNP-15 manufactured by Cook, Inc..

Event Text Entries

[1762] Surgeon was performing a paracentesis on patient, the needle broke, leaving a portion of the needle in the patient's abdominal wall in llo. Patient was very obese so needle is in adipose tissue. Abdominal x-ray perform to confirm location of needledevice 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: yes. Corrective actions: other. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1880
• MDR Report Key: 1880
• Date Received: 1992-11-20
• Date of Report: 1992-11-07
• Date of Event: 1992-11-03
• Date Facility Aware: 1992-11-03
• Report Date: 1992-11-07
• Date Reported to FDA: 1992-11-07
• Date Reported to Mfgr: 1992-11-05
• Date Added to Maude: 1992-12-14
• 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: NEEDLE
• Generic Name: NEEDLE
• Product Code: FHR
• Date Received: 1992-11-20
• Model Number: N/A
• Catalog Number: CNP-15
• Lot Number: 737216272A
• ID Number: N/A
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Device Age: 01-SEP-92
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 1755
• Manufacturer: COOK, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-11-20