inforMED
MalfunctionOIE

BD VACUTAINER® PLASTIC URINE COLLECTION CUP WITH INTEGRATED SAMPLING DEVICE

Received Nov 9, 2015 · Event occurred Oct 15, 2015

Report 1917413-2015-00001 · MDR key 5210728

Device

Generic name

Collection Cup

Catalog number

364975

Lot number

UNKNOWN

Product problems

  • Improper or Incorrect Procedure or Method

Patient

Not reported

  • Needle Stick/Puncture

Narrative

Additional Manufacturer Narrative

RESULTS- A SAMPLE IS NOT AVAILABLE FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. CONCLUSION- WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

Description of Event or Problem

IT WAS REPORTED THAT A LAB TECH RECEIVED A SAMPLE IN A BD VACUTAINER PLASTIC URINE COLLECTION CUP. THE DEVICE'S LID WAS WRAPPED WITH PARAFILM TO PREVENT LEAKING AND THE PROTECTIVE COVER ON THE NEEDLE WAS NOT IN PLACE. AS THE TECH WAS TRYING TO REMOVE THE LID FROM THE CUP, THE INDEX FINGER OF HIS LEFT HAND WENT INSIDE THE LID RECEPTACLE AND HE STUCK HIMSELF ON THE NEEDLE. HE WAS EVALUATED FOR BLOODBORNE PATHOGENS. THE SOURCE PATIENT WAS SEEING AN INFECTIOUS DISEASE DOCTOR FOR (B)(6).