60016-2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-07-22 for 60016-2 manufactured by Bard Access (davol Evermed).

Event Text Entries

[4821] Pt. Came to e. R. With chest pain 1633, 3/25/93. X-ray indicated a cath tube in a pulmonary vein. Upon removal on 3/26/93 tubing identified as portion of catheter. The catheter had been removed on 1/26/93 with the broken portion remaining undetected in the pt. Device labeled for single use. Patient medical status prior to event: unknown. There was not multiple patient involvement. Device not serviced in accordance with service schedule. 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: actual device involved in incident was evaluated, visual examination. Results of evaluation: telemetry failure, tubing. Conclusion: invalid data, device failure occurred and was related to event. 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: 6782
• MDR Report Key: 6782
• Date Received: 1993-07-22
• Date of Event: 1993-03-25
• Date Facility Aware: 1993-03-26
• Date Reported to Mfgr: 1993-04-05
• Date Added to Maude: 1993-10-15
• 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

• Generic Name: HICKMAN SINGLE-LUMEN 9.6 FR CATHETER
• Product Code: GBS
• Date Received: 1993-07-22
• Catalog Number: 60016-2
• Operator: OTHER
• Device Availability: Y
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 6465
• Manufacturer: BARD ACCESS (DAVOL EVERMED)

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-07-22