BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 11750478 · Received April 29, 2021

    Report

    Report Number
    1213809-2021-00281
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    April 2, 2021
    Report Date
    May 12, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052715
    PMA / PMN Number
    K011103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: 37 OF SEALED PACKAGED SYRINGE WERE RECEIVED, CONFIRMED TO BE FROM BATCH 9112885 (P/N 305271). THE SAMPLES WERE VISUALLY EVALUATED. NO DAMAGE OR DEFORMITIES WERE OBSERVED IN THE SYRINGES¿ LUER THREAD, LUER COLLAR, OR NEEDLE HUBS. ALL OF THE SEALED SAMPLES WERE TESTED FOR NEEDLE RETRACTION FORCE PER PROCEDURE. THREE OUT OF 37 SYRINGES HAD RETRACTION FORCES SLIGHTLY ABOVE THE SPECIFICATION, WHILE 34 SYRINGES WERE WITHIN TARGET RANGE. NO DEFECTS THAT COULD CONTRIBUTE TO LEAKAGE WERE FOUND IN THE RETURNED SAMPLES. IT IS UNCLEAR WHAT THE ¿NEEDLE FELL OFF¿ DEFECT WAS. IT IS POSSIBLE THE CANNULA OF THE NEEDLE RETRACTED BEFORE REACHING THE ZERO LINE. HOWEVER, TESTING DID NOT SHOW LOW ACTIVATION FORCES. THEREFORE, THE DEFECT COULD NOT BE CONFIRMED AND ROOT CAUSE IS UNDETERMINED. SINCE THE REPORTED DEFECTS COULD NOT BE CONFIRMED, CORRECTIVE ACTIONS ARE NOT NECESSARY. 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 · 1

    IT WAS REPORTED THAT THE BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE "SQUIRTED" OUT VACCINE MEDICINE AND THE PATIENT HAD TO BE INJECTED A SECOND TIME. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PAST 2 DAYS I¿VE HAD MAJOR SYRINGE MALFUNCTIONS, YOUR BD INTEGRA SYRINGE, REF 305271, 3ML 23G X 1INCH, LOT 9112886. YESTERDAY, AFTER DRAWING UP A MODERNA COVID SHOT, THE NEEDLE FELL OFF THE SYRINGE AND THE DOSE WAS LOST. I HABITUALLY TWIST THE LUERLOK TO ENSURE TIGHTNESS, BEFORE DRAWING A SHOT, WHICH MAKES THE SYRINGE FAILURE THAT MUCH MORE DISTRESSING. TODAY, A SYRINGE FAILED WHILE INJECTING A PATIENT, CONTENTS SQUIRTING OUT AROUND THE LUERLOK AND RUNNING DOWN THE PATIENT¿S ARM. OBVIOUSLY, THE IMMUNIZATION HAD TO BE REPEATED. SO, 2 MAJOR FAILURES, ONE LOT#. ONE PATIENT HAD HER IMMUNIZATION DELAYED 1 DAY. ONE PATIENT HAD TO BE JABBED TWICE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE "SQUIRTED" OUT VACCINE MEDICINE AND THE PATIENT HAD TO BE INJECTED A SECOND TIME. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PAST 2 DAYS I¿VE HAD MAJOR SYRINGE MALFUNCTIONS, YOUR BD INTEGRA SYRINGE, REF 305271, 3ML 23G X 1INCH, LOT 9112886. YESTERDAY, AFTER DRAWING UP A MODERNA COVID SHOT, THE NEEDLE FELL OFF THE SYRINGE AND THE DOSE WAS LOST. I HABITUALLY TWIST THE LUERLOK TO ENSURE TIGHTNESS, BEFORE DRAWING A SHOT, WHICH MAKES THE SYRINGE FAILURE THAT MUCH MORE DISTRESSING. TODAY, A SYRINGE FAILED WHILE INJECTING A PATIENT, CONTENTS SQUIRTING OUT AROUND THE LUERLOK AND RUNNING DOWN THE PATIENT¿S ARM. OBVIOUSLY, THE IMMUNIZATION HAD TO BE REPEATED. SO, 2 MAJOR FAILURES, ONE LOT#. ONE PATIENT HAD HER IMMUNIZATION DELAYED 1 DAY. ONE PATIENT HAD TO BE JABBED TWICE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646169 BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE PISTON SYRINGE MEG BECTON DICKINSON MEDICAL SYSTEMS 305271 9112885 30382903052715

    Patients

    Seq Age Sex Outcome Treatment
    1