MalfunctionLRT
QUALI-QUICK TESTER
Received May 15, 1998
Report MW4002216 · MDR key 168711
Device
Generic name
Sterility Tester
Manufacturer
Medical Products, Inc.Model number
NACatalog number
NI
Lot number
7E107
Product problems
- Contamination
- Crack
- Fluid/Blood Leak
Patient
NA
Narrative
Description of Event or Problem
THE BROTH, WHICH SHOWED GROWTH, WAS TURBID. A SMALL HAIRLINE CRACK WAS NOTED NEAR THE BOTTOM OF THE VIAL ALTHOUGH THERE WAS ONLY SLIGHTLY LESS VOLUME IN THE VIAL. HAD THE TURBIDITY NOT BEEN NOTICED, THE VIAL COULD HAVE BEEN USED TO CHECK THE STERILITY OF A PREPARED PRODUCT AND GROWTH COULD HAVE BEEN REPORTED ERRONEOUSLY.