MalfunctionCEK
DIPPER URINE DIPSTICK CONTROL
Received Jul 6, 2015 · Event occurred Jun 5, 2015
Report 2020715-2015-00001 · MDR key 4898202
Device
Generic name
Urinalysis Control, 862.1660
Manufacturer
Quantimetrix CorporationCatalog number
1440-01
Lot number
44822
Product problems
- Device Difficult to Setup or Prepare
Patient
Not reported
- Laceration(s)
Narrative
Description of Event or Problem
PER THE OFFICE MANAGER AT THE FACILITY - THE GLASS VIAL CONTAINING QUALITY CONTROL MATERIAL, DIPPER URINE DIPSTICK CONTROL BROKE IN THE MEDICAL ASSISTANT'S HAND WHEN SHE ATTEMPTED TO TWIST OFF THE CAP. THE CUT OCCURRED ON THE INDEX FINGER ON RIGHT HAND. THE OFFICE MANAGER MENTIONED THAT THE CUT WAS ADDRESSED BY A PHYSICIAN AND REQUIRED ONLY A BAND AID AND WAS CONSIDERED A LITTLE MINOR CUT. THE MEDICAL ASSISTANT WAS NOT WEARING GLOVES WHEN SHE ATTEMPTED TO TWIST OFF CAP.