HICKMAN CATHETER, 10 FRENCH 60063-2 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-07-01 for HICKMAN CATHETER, 10 FRENCH 60063-2 NA manufactured by Bard.

Event Text Entries

[2662] On 2/11/93, the patient underwent a laparoscopic cholecystectomy and insertion of a right hickman catheter. On 5/3/93, the patient developed pain at the hickman catheter entrance site ( under the right clavicle) during adriamycin infusion in the physician's office. On 5/5/93 under fluoroscopic guidance, each part of the hickman was injected with contrast separately. When the red cap was injected, extravasation was noted at the level where the right clavicle crosses the first rib. This is consistent with a leak in the catheter from this site. The catheter was removed on 5/5/93device labeled for single use. Patient medical status prior to event: unknown. 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: device returned to manufacturer/dealer/distributor. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 5799
• MDR Report Key: 5799
• Date Received: 1993-07-01
• Date of Report: 1993-06-10
• Date of Event: 1993-05-04
• Date Facility Aware: 1993-05-04
• Report Date: 1993-06-10
• Date Reported to FDA: 1993-06-10
• Date Reported to Mfgr: 1993-06-01
• Date Added to Maude: 1993-07-27
• 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 CATHETER, 10 FRENCH
• Generic Name: NA
• Product Code: JCY
• Date Received: 1993-07-01
• Model Number: 60063-2
• Catalog Number: NA
• Lot Number: NA
• ID Number: NA
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 5498
• Manufacturer: BARD

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-07-01