FDA Adverse Event Other Summary report: N

SURECAN SAFETY HUBER NEEDLE

MDR report key: 507193 · Received January 6, 2004

Report

Report Number
MW1030765
Event Type
Other
Date Received
January 6, 2004
Date of Event
January 2, 2004
Report Date
January 6, 2004
Manufacturer
BRAUN MEDICAL, INC.
Product Code
FMI
Report Source
Voluntary report
Reporter Location
CO, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

PT HAD C.I. OF 5FU GOING FOR 4 DAYS VIA INFUSE PORT. CONNECTOR SITE STARTED TO LEAK. WHITE CONNECTOR PORT OF Y-TYPE HUBER NEEDLE. NEW CAP IN PLACE - NO FURTHER LEAKS. Y-SITE INFUSION SET AND NEEDLE ONE PIECE FROM MFR.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SURECAN SAFETY HUBER NEEDLE INFUSION SET WITH RIGHT ANGLE SAFETY HUBER NEEDLE FMI BRAUN MEDICAL, INC. US 201 6H 60469828

Patients

Seq Age Sex Outcome Treatment
1 65 YR Other