BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE CONTROL 10ML LL

    MDR report key: 10571373 · Received September 23, 2020

    Report

    Report Number
    1213809-2020-00649
    Event Type
    Malfunction
    Date Received
    September 23, 2020
    Date of Event
    August 28, 2020
    Report Date
    September 24, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096955
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THIRTEEN 10ML CONTROL SYRINGES IN FULLY SEALED BLISTER PACKS CONFIRMED TO BE FROM BATCH 0002432 (P/N (B)(6)) WERE RECEIVED AND EVALUATED. THE PLUNGER RODS WERE EXERCISED IN EACH OF THE SYRINGES AND THE STOPPER APPEARED TO BE SECURE AS NO SEPARATION OCCURRED. NO DEFECT WAS OBSERVED IN THE SAMPLES 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE CONTROL 10ML LL STOPPER SEPARATED FROM THE PLUNGER DURING USE ON A PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ON FRIDAY (B)(6)2020 WHILE ONE OF OUR PHYSICIANS WAS USING THE 10ML CONTROL SYRINGE (ITEM #306695) THE DOUBLE RING ATTACHED TO THE BARREL DETACHED. THE DETACHMENT HAPPENED WHILE IN USE ON A PATIENT. THANKFULLY NO HARM WAS CAUSED TO THE PATIENT BUT PER DR. XXX COULD HAVE HAD A DIFFERENT OUTCOME.".

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE CONTROL 10ML LL STOPPER SEPARATED FROM THE PLUNGER DURING USE ON A PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ON FRIDAY (B)(6) 2020 WHILE ONE OF OUR PHYSICIANS WAS USING THE 10ML CONTROL SYRINGE (ITEM #306695) THE DOUBLE RING ATTACHED TO THE BARREL DETACHED. THE DETACHMENT HAPPENED WHILE IN USE ON A PATIENT. THANKFULLY NO HARM WAS CAUSED TO THE PATIENT BUT PER DR. XXX COULD HAVE HAD A DIFFERENT OUTCOME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041417 SYRINGE CONTROL 10ML LL PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309695 0002432 30382903096955

    Patients

    Seq Age Sex Outcome Treatment
    1 Other