PENCAN®

Description of Event or Problem

THE EVENT BELOW IS SUSPECTED TO BE PART OF A NATIONAL RECALL FROM HUONS, MFG OF ROUGHLY 8% OF BUPIVACAINE INCLUDED IN THE BBRAUN KITS. KIT LOT #S 0061926831, 0061026831, 0061919584. THE PATIENT PRESENTED FOR CERVICAL CERCLAGE AND A SPINAL ANESTHETIC WAS PLANNED AND ADMINISTERED. DESPITE A TECHNICALLY STRAIGHTFORWARD SPINAL AND INJECTION OF 1ML OF HYPERBARIC 0.75% BUPIVACAINE FROM THE SPINAL KIT INTO THE CEREBROSPINAL FLUID, NO DETECTABLE ANESTHETIC LEVEL WAS OBTAINED AND THE PATIENT INSTEAD RECEIVED GENERAL ANESTHESIA FOR THE PROCEDURE. I AM ALSO AWARE OF TWO OTHER SIMILAR EVENTS WITH OTHER ANESTHESIOLOGISTS (DR. [REDACTED] AND DR. [REDACTED]) THAT HAVE OCCURRED IN THE LAST COUPLE OF MONTHS. [REDACTED] CORPORATE SUPPLY CHAIN NOTIFIED VIA EMAIL. [REDACTED] PER DR. [REDACTED], NOT REPORTED AS OCCURRING AT [REDACTED]. [REDACTED] BOTH DRS. [REDACTED] AND [REDACTED] HAVE HAD SPINAL ANESTHETICS WITH HYPERBARIC BUPIVACAINE FROM THE KIT THAT FAILED DESPITE TECHNICALLY STRAIGHT-FORWARD PROCEDURES IN THE LAST COUPLE WEEKS. DR. [REDACTED] TOLD ME ABOUT HERS, AND THEN WHEN DR. [REDACTED] HAD ONE A WEEK LATER, I ASKED HIM TO TAKE A PIC OF THE KIT LOT # SO WE CAN INVESTIGATE SINCE IT SEEMS LIKE A BIG COINCIDENCE. THEY ARE QUESTIONING THE EFFICACY OF THE INCLUDED BUPIVACAINE 0.75% W/ DEXTROSE 8.25%. THIS IS THE BBRAUN PENCAN SPINAL NEEDLE TRAY REF#333851 THAT IS IN USE AT [REDACTED], [REDACTED] AND [REDACTED]. MANUFACTURER RESPONSE FOR MEDICATION, ANESTHETIC, BUPIVACAINE (PER SITE REPORTER). BBRAUN COMPLETED AN INVESTIGATION AND SENT US A LETTER SAYING THEY HAD CONFIRMED WITH THEIR MANUFACTURER (UN-NAMED) THAT THE MEDICATION WAS FINE.