BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 8911470 · Received August 20, 2019

    Report

    Report Number
    1213809-2019-00846
    Event Type
    Malfunction
    Date Received
    August 20, 2019
    Date of Event
    July 31, 2019
    Report Date
    October 2, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052715
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE 3ML INTEGRA SYRINGE WITH NEEDLE ASSEMBLY IN AN OPENED BLISTER PACK FORM BATCH 9001858 (P/N 305271) WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THE RETRACTION MECHANISM WAS PARTIALLY ACTIVATED WITH THE STOPPER AT THE 1/2ML MARKING. THE CUTTER WAS EXPOSED THROUGH THE STOPPER BUT TOO FAR AWAY FROM THE HUB FOR THE NEEDLE TO RETRACT. THIS IS A REJECTABLE CONDITION PER PRODUCT SPECIFICATION. A PHYSICAL UNUSED SAMPLE IS REQUIRED FOR A MORE THOROUGH EVALUATION AND POTENTIAL ROOT CAUSE DETERMINATION. 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

    MATERIAL NO. 305271, BATCH NO. 9001858. IT WAS REPORTED THAT DURING USE OF THE BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE THE STOPPER SEPARATED FROM PLUNGER WHILE INJECTING MEDICINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER STATED THAT IT WAS HIS FIRST TIME USING THE SYRINGE AND WHEN HE WENT TO INJECT, STOPPER WENT THROUGH THE PLUNGER.

    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.

    Description of Event or Problem · 1

    MATERIAL NO. 305271, BATCH NO. 9001858. IT WAS REPORTED THAT DURING USE OF THE BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE THE STOPPER SEPARATED FROM PLUNGER WHILE INJECTING MEDICINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER STATED THAT IT WAS HIS FIRST TIME USING THE SYRINGE AND WHEN HE WENT TO INJECT, STOPPER WENT THROUGH THE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703866 BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE PISTON SYRINGE MEG BECTON DICKINSON MEDICAL SYSTEMS 9001858 30382903052715

    Patients

    Seq Age Sex Outcome Treatment
    1 Other