84JXG UNK

MEDWATCH REPORT# RECEIVED ON 12/4/2009: LUMBAR DRAIN DISCONTINUED WITHOUT RESISTANCE. TIP NOT INTACT. MD SPOKE WITH THE PT IMMEDIATELY FOLLOWING THE REMOVAL OF THE LUMBAR DRAIN AND EXPLAINED TO THEM THAT DURING THE ROUTINE REMOVAL OF THE LUMBAR DRAIN, A PORTION OF IT DISLODGED AND REMAINED IN THE PT. DRAIN WAS INSERTED IN SURGERY AND REMOVED IN SICU..., NO PACKAGING AVAILABLE. DRAIN COMES IN A KIT IN THE OPERATING ROOM. UPDATE 12/22/2009: THERE IS NO C/N OR L/N INFO AVAILABLE AS THE PACKAGING WAS DISCARDED IN THE OR. THE CATHETER CAME FROM A DRAINAGE KIT. THE CATHETER IS AVAILABLE FOR RETURN. THE HOSP DOES NOT PROVIDE PHYSICIAN INFO. IMPLANT DATE IS UNK. NO REPLACEMENT NEEDED. PT HAD TO HAVE REVISION SURGERY TO REMOVE FRAGMENT. RISK MGR WOULD LIKE A COPY OF ANALYSIS REPORT.

THE DEVICE HAS NOT BEEN RETURNED TO THE MFR.