MINI GPS 6 PACK
Received Oct 2, 2014 · Event occurred Aug 21, 2014
Report 0001825034-2014-07902 · MDR key 4133900
Device
Generic name
Blood Bank Supplies
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
800-1007A
Lot number
400389
Product problems
- Break
- Contamination
- Improper Flow or Infusion
Patient
Not reported
- No Code Available
Narrative
Description of Event or Problem
IT WAS REPORTED THAT PATIENT UNDERWENT A PROCEDURE UTILIZING A PLATELET SEPARATION KIT FOR THE EXTRACTION OF PLATELET RICH PLASMA (PRP) ON (B)(6) 2014. DURING THE PROCEDURE, THE KIT DID NOT SEPARATE THE PRP PROPERLY AND BECAME CONTAMINATED WITH WHAT LOOKED LIKE RED BLOOD CELLS (RBCS). THE KIT APPEARED TO HAVE A BREAK IN THE SEAL BETWEEN THE CHAMBERS. A DIFFERENT KIT WAS USED TO COMPLETE THE PROCEDURE; HOWEVER, A DELAY OF AT LEAST 30 MINUTES OCCURRED WHILE THE OTHER KIT WAS SET UP.
Additional Manufacturer Narrative
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF THE INSPECTION RECORDS AND CERTIFICATE OF CONFORMANCE, INDICATES THAT LOT WAS RECEIVED WITH NO RECORDED ANOMALY OR DEVIATION.