*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-05-14 for * manufactured by Arrow Intl., Inc..

Event Text Entries

[61194] Pt presented in the er with facial injuries sustained in a motorvehicle accident. Pt had history of dialysis and end-stage renal disease. Pt was catheterized (left femoral vein) and this was used to infuse volumes of blood and fluids, to which the pt responded positively. Pt was transferred to icu. Pt became unstable and developed a swollen abdomen. Pt was taken to the or. Upon opening the pt it was discovered that the catheter had perforated the left femoral vein. The pt expired.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 91936
• MDR Report Key: 91936
• Date Received: 1997-05-14
• Date of Report: 1997-05-09
• Date of Event: 1997-05-06
• Date Facility Aware: 1997-05-06
• Report Date: 1997-05-09
• Date Reported to FDA: 1997-05-09
• Date Reported to Mfgr: 1997-05-09
• Date Added to Maude: 1997-05-21
• 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
• Reporter Occupation: BIOMEDICAL ENGINEER
• Health Professional: 3
• Initial Report to FDA: 3
• 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: *
• Generic Name: TRIPLE LUMEN (FEMORAL) CATHETER
• Product Code: LFK
• Date Received: 1997-05-14
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: 7 FR., 20 CM, 0.035"DIA
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 90815
• Manufacturer: ARROW INTL., INC.
• Manufacturer Address: P.O. BOX 12888 READING PA 19612 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1997-05-14