NEEDLE SP S/SU 25GA TW 3-1/2IN WHITACRE

Additional Manufacturer Narrative

INVESTIGATION RESULTS: TWO SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. UPON INSPECTION, ONE NEEDLE MET THE EXPECTED SPECIFICATION CHARACTERISTICS, WHILE THE OTHER HAD A BROKEN/MISSING MOLDED HANDLE KEY AND A BROKEN HANDLE OFF THE STYLET. THE REPORTED INCIDENT COULD BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE COULD EITHER BE TRACED TO MANUFACTURING DURING ASSEMBLY OR DURING HANDLING OF THE PRODUCT. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS.

Description of Event or Problem

NO ADDITIONAL INFORMATION.

Additional Manufacturer Narrative

INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

Description of Event or Problem

MATERIAL #:405138. BATCH#:4123754. VERBATIM: AHS MDIP # 2527 RESIDENT WAS PERFORMING A SPINAL ANESTHETIC ON A PATIENT IN THE HOLDING AREA PRIOR TO SURGERY. WHEN THEY REMOVED THE NEEDLE, THEY NOTICED THE STILETTE WAS MISSING. UPON CLOSER INSPECTION, YOU COULD SEE THAT THERE WAS A METAL STUB AT THE BASE OF THE ORANGE HUB BUT THE ~3INCH LONG STILETTE WAS MISSING. A FULL SEARCH WAS PERFORMED AND IT WAS NOT LOCATED. A FLAT PLATE X-RAY WAS PERFORMED AND IT WAS NOT SEEN ON X-RAY, NOR WAS IT SEEN ON CT. AT THIS POINT, PATIENT WAS CLEARED FOR SURGERY AND SURGERY PROCEEDED, DELAYED FROM EARLIER. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT? NONE REPORTED. DELAYED SURGERY TIME.