Description of Event or Problem · 0
MULTIPLE REPORTS OF MEDICATION FAILURE OF THE BUPIVICAINE INCLUDED IN THE (B)(6) NO EPINEPHRINE 25G WHITACRE SPINAL TRAYS. 3 SEPARATE INCIDENTS (IN A PERIOD OF 2.5 WEEKS) IN WHICH NO MEDICATION EFFECT WAS PRODUCED AFTER INTRATHECAL INJECTION OF THE 0.75% HYPERBARIC BUPIVICAINE PROVIDED IN THE KIT. EACH INCIDENT WAS REPORTED BY A DIFFERENT ANESTHESIOLOGIST, ONE ON NIGHT SHIFT, AND TWO ON DAY SHIFTS THAT WERE A WEEK APART. CHART REVIEW AND DIRECT FOLLOW-UP WITH EACH INDIVIDUAL ANESTHESIOLOGIST REVEALED THAT, IN ALL 3 CASES, THE SPINAL BLOCK WAS NOTED TO BE UNCOMPLICATED, NOT DIFFICULT AND WITH GOOD, CLEAR CSF RETURN AS EXPECTED. THIS CONFIRMED WITH A HIGH DEGREE OF CERTAINTY THAT MEDICATION FAILURE, NOT PROVIDER FAILURE OR PATIENT CLINICAL/ANATOMIC/PHYSIOLOGIC FACTORS, WAS THE LIKELY CAUSE OF ALL 3 REPORTED BLOCK FAILURES. IN ALL THREE CASES, ANESTHESIOLOGIST CONFIRMED VERIFYING EXPIRATION DATE HAD NOT PASSED PRIOR TO OPENING KIT. SPECIFIC KIT INFORMATION WAS DOCUMENTED IN 1 OF THE 3 REPORTED INCIDENTS: REF# A4173-25, LOT# 6142417, MANUFACTURE DATE: 08/06/2025, EXP DATE: 09/01/2026. PT CODE: 4582. DEVICE CODE: 3023. REFERENCE REPORTS MW5179529, MW5179531.