FDA Adverse Event Malfunction Summary report: N

VENOJECT II SODIUM FLUORIDE TUBE

MDR report key: 36956 · Received September 6, 1996

Report

Report Number
MW1009890
Event Type
Malfunction
Date Received
September 6, 1996
Manufacturer
TERUMO MEDICAL CORP.
Product Code
JKA
Product Problem
Yes
Report Source
Voluntary report
Reporter Occupation
MEDICAL TECHNOLOGIST

Narratives

Description of Event or Problem · 1

RPTR RECEIVED 2 BOXES OF SODIUM FLUORIDE TUBES. THE BOXES WERE UNDAMAGED, BUT UPON OPENING IT WAS DISCOVERED THAT MOST OF THE TUBES WERE FLATTENED OR COLLAPSED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 VENOJECT II SODIUM FLUORIDE TUBE BLOOD COLLECITON TUBE 5ML JKA TERUMO MEDICAL CORP. * TL0741

Patients

Seq Age Sex Outcome Treatment
1 *