Description of Event or Problem · 1
THORACENTESIS WAS PERFORMED USING THE 22G 2" NEEDLE FROM THE THORACENTESIS TRAY. 250CC FLUID WAS OBTAINED, AFTER INSTILLING LOCAL ANESTHESIA. UPON REMOVING THE 50CC SYRINGE (TO WHICH THE 22G NEEDLE WAS ATTACHED), THE NEEDLE CAME OFF OF THE RUBBER HUB. THE HUB REMAINED ATTACHED TO THE SYRINGE, WITH NO REMNANT OF THE NEEDLE ATTACHED. AN ATTEMPT WAS MADE TO RETRIEVE THE NEEDLE THROUGH A SMALL SKIN INCISION, BUT WAS UNSUCCESSFUL. THE PT WILL PROBABLY REQUIRE SURGICAL RETRIEVAL. THE DISTRIBUTOR IS RECALLING THE ENTIRE LOT.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE. CONCLUSION: DEVICE DISCARDED - UNABLE TO FOLLOW-UP. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RECALLED BY MANUFACTURER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.