BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 9294351 · Received November 8, 2019

    Report

    Report Number
    1213809-2019-01117
    Event Type
    Malfunction
    Date Received
    November 8, 2019
    Date of Event
    October 22, 2019
    Report Date
    January 14, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052708
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 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. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    MATERIAL NO: 305270; BATCH NO: 9093523. IT WAS REPORTED THAT DURING USE OF THE BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE THERE WAS RESISTANCE WHEN DRAWING UP VACCINE AND WHEN ADMINISTERING THE VACCINE. "WHEN THE PLUNGER WAS DEPRESSED (WITH THE NEEDLE INSIDE THE PATIENT'S ARM), THE VACCINE LIQUID SQUIRTED OUT AT THE JUNCTION WHERE THE NEEDLE AND SYRINGE SCREW TOGETHER INSTEAD OF GOING INTRAMUSCULAR." THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WERE 2 INCIDENTS TOOK PLACE THIS PAST MONTH WITH THE SYRINGES WHILE ADMINISTERING A VACCINE. UPON DRAWING UP THE VACCINE, THERE WAS SOME RESISTANCE (TOOK SEVERAL ATTEMPTS--IT WAS JUST PULLING UP AIR AT FIRST). THEN WHEN THE PLUNGER WAS DEPRESSED (WITH THE NEEDLE INSIDE THE PATIENT'S ARM), THE VACCINE LIQUID SQUIRTED OUT AT THE JUNCTION WHERE THE NEEDLE AND SYRINGE SCREW TOGETHER INSTEAD OF GOING INTRAMUSCULAR.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO: 305270 BATCH NO: 9093523. IT WAS REPORTED THAT DURING USE OF THE BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE THERE WAS RESISTANCE WHEN DRAWING UP VACCINE AND WHEN ADMINISTERING THE VACCINE. "WHEN THE PLUNGER WAS DEPRESSED (WITH THE NEEDLE INSIDE THE PATIENT'S ARM), THE VACCINE LIQUID SQUIRTED OUT AT THE JUNCTION WHERE THE NEEDLE AND SYRINGE SCREW TOGETHER INSTEAD OF GOING INTRAMUSCULAR." THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WERE 2 INCIDENTS TOOK PLACE THIS PAST MONTH WITH THE SYRINGES WHILE ADMINISTERING A VACCINE. UPON DRAWING UP THE VACCINE, THERE WAS SOME RESISTANCE (TOOK SEVERAL ATTEMPTS--IT WAS JUST PULLING UP AIR AT FIRST). THEN WHEN THE PLUNGER WAS DEPRESSED (WITH THE NEEDLE INSIDE THE PATIENT'S ARM), THE VACCINE LIQUID SQUIRTED OUT AT THE JUNCTION WHERE THE NEEDLE AND SYRINGE SCREW TOGETHER INSTEAD OF GOING INTRAMUSCULAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088666 BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE PISTON SYRINGE MEG BECTON DICKINSON MEDICAL SYSTEMS 9093523 30382903052708

    Patients

    Seq Age Sex Outcome Treatment
    1 Other