BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 11236655 · Received January 27, 2021

    Report

    Report Number
    1213809-2021-00043
    Event Type
    Malfunction
    Date Received
    January 27, 2021
    Date of Event
    January 4, 2021
    Report Date
    June 22, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052708
    PMA / PMN Number
    K011103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. LOT # 4002409. D.4. MEDICAL DEVICE EXPIRATION DATE: 12/31/2018. D.10. DEVICE AVAILABLE FOR EVALUATION? YES. D.11. D.11.RETURNED TO MANUFACTURER ON: 2021-06-02. H.4. DEVICE MANUFACTURE DATE: 01/23/2014.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A SHARPS CONTAINER, AS WELL AS THREE SEALED PACKAGED INTEGRA SYRINGES AND AN OPENED EMPTY PACKAGE WERE RECEIVED, CONFIRMED TO BE FROM BATCH #4002409 (P/N 305270). THE SHARPS CONTAINER CONTAINED ANOTHER OPENED BLISTERPACK FROM THE SAME BATCH AND A PLASTIC BAG WITH SYRINGE FRAGMENTS. THE FRAGMENTS INCLUDED AN INTEGRA BARREL, A SHIELDED INTEGRA NEEDLE WITH ITS HUB PUNCTURED AND NO CANNULA REMAINING, HALF OF AN INTEGRA PLUNGER ROD FROM THE STOPPER¿S END, AND A WHOLE INTEGRA PLUNGER ROD BENT AND BROKEN IN HALF BUT STILL ATTACHED AT THE POINT OF BREAK. THE HALF OF A PLUNGER ROD HAD ITS STOPPER STILL ATTACHED AND THE CUTTER WAS THROUGH THE STOPPER IN ITS CENTER. NO DEFECTS WERE OBSERVED WITH THAT PART OF THE PLUNGER ROD, ASIDE FROM IT MISSING THE BOTTOM HALF. THE FULL PLUNGER ROD HAD A MANGLED TIP WITH NO STOPPER AND NO CUTTER PRESENT. IT WAS BENT AWAY FROM THE BREAKPOINT WITH CANNULA VISIBLE THROUGH THE OPENING. POTENTIAL ROOT CAUSE FOR THE DAMAGED PLUNGER ROD DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. IT IS POSSIBLE THE AFFECTED PLUNGER RODS WERE NOT PROPERLY POSITIONED WHEN ENTERING THE ASSEMBLY DIAL RESULTING IN MAJOR DAMAGE. PROCEDURE WAS UPDATED SEP 2021 TO INCLUDE ADDITIONAL PROCESS CHECKS AND VERIFICATIONS AT ASSEMBLY AT EACH BATCH CHANGE. BATCH 4002409 (P/N 305270) WAS MANUFACTURED IN JAN 2014 BEFORE THE ABOVE-MENTIONED ACTIONS TOOK PLACE. IT EXPIRED IN DEC 2018 AND SHOULD NOT BE USED. NO ADDITIONAL ACTIONS ARE RECOMMENDED AT THIS TIME. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PLUNGER IN THE BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE BROKE, CAUSING THE STOPPER TO FALL OUT AND TESTOSTERONE TO SPILL ONTO THE INJECTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DAUGHTER OF CONSUMER REPORTED ISSUE ON BEHALF OF HER DAD: STATED, LAST MONTH, WHEN TAKING INJECTION THE PLUNGER BROKE CAUSING STOPPER TO FALL OUT OF SYRINGE AND "TESTOSTERONE" SPILLED ONTO INJECTION SITE. STATED, MEDICATION WAS WASTED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PLUNGER IN THE BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE BROKE, CAUSING THE STOPPER TO FALL OUT AND TESTOSTERONE TO SPILL ONTO THE INJECTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DAUGHTER OF CONSUMER REPORTED ISSUE ON BEHALF OF HER DAD: STATED, LAST MONTH, WHEN TAKING INJECTION THE PLUNGER BROKE CAUSING STOPPER TO FALL OUT OF SYRINGE AND "TESTOSTERONE" SPILLED ONTO INJECTION SITE. STATED, MEDICATION WAS WASTED."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4). INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLUNGER IN THE BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE BROKE, CAUSING THE STOPPER TO FALL OUT AND TESTOSTERONE TO SPILL ONTO THE INJECTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DAUGHTER OF CONSUMER REPORTED ISSUE ON BEHALF OF HER DAD: STATED, LAST MONTH, WHEN TAKING INJECTION THE PLUNGER BROKE CAUSING STOPPER TO FALL OUT OF SYRINGE AND "TESTOSTERONE" SPILLED ONTO INJECTION SITE. STATED, MEDICATION WAS WASTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131339 BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE PISTON SYRINGE MEG BECTON DICKINSON MEDICAL SYSTEMS 305270 4002409 30382903052708

    Patients

    Seq Age Sex Outcome Treatment
    1