HICKMAN 12.0 FR ROUND DUAL LUMEN CATHETER 60062-2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-02-19 for HICKMAN 12.0 FR ROUND DUAL LUMEN CATHETER 60062-2 manufactured by Davol.

Event Text Entries

[189] Difficulty retracting sheath resulting in significant blood loss. Patient had to be transfused. Both surgeons identified problems with retracting the sheathdevice 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: use of all similar devices stopped temporarily. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 247
• MDR Report Key: 247
• Date Received: 1992-02-19
• Date of Report: 1992-01-31
• Date of Event: 1992-01-21
• Date Facility Aware: 1992-01-22
• Report Date: 1992-01-31
• Date Reported to FDA: 1992-01-31
• Date Reported to Mfgr: 1992-01-31
• Date Added to Maude: 1992-04-13
• 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: HICKMAN 12.0 FR ROUND DUAL LUMEN CATHETER
• Product Code: FGH
• Date Received: 1992-02-19
• Model Number: 60062-2
• Lot Number: H3036006221
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Device Age: 01-NOV-89
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 243
• Manufacturer: DAVOL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-02-19