TRIPLE LUMEN CATHETER AK 15703 B

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-06-17 for TRIPLE LUMEN CATHETER AK 15703 B manufactured by Arror International.

Event Text Entries

[18166937] Triple lumen catheter inserted on may 31, 1993 at approximately 3:00 pm. Patient tolerated procedure. Ports heparinized and taped in place. Placement confirmed via x-ray. At 3:30 pm. Tpn and interlipids restarted via distal port. At 6:00 pm, patient ambulating in the hall. At approximately 9:00 pm, patient reported "iv leaking". Brown port found disconnected from tubing. Tubing flushed with heparin and clamped. Dressing applied. 6/1/93 - triple lumen catheter removed and returned to manufacture via the representative. Device 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 evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: manufacturing, telemetry failure, unanticipated adverse reaction - short term, port. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service, device returned to manufacturer/dealer/distributor. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4992
• MDR Report Key: 4992
• Date Received: 1993-06-17
• Date of Report: 1993-06-01
• Date of Event: 1993-05-31
• Date Facility Aware: 1993-05-31
• Report Date: 1993-06-01
• Date Reported to Mfgr: 1993-06-01
• Date Added to Maude: 1993-06-22
• 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: TRIPLE LUMEN CATHETER
• Product Code: GBP
• Date Received: 1993-06-17
• Catalog Number: AK 15703 B
• Lot Number: AK-1-070-3
• Device Expiration Date: 1995-12-01
• Operator: OTHER
• Device Availability: N
• Device Age: 01-APR-93
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 4695
• Manufacturer: ARROR INTERNATIONAL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-06-17