BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LL BNS

    MDR report key: 8466359 · Received March 29, 2019

    Report

    Report Number
    1213809-2019-00394
    Event Type
    Malfunction
    Date Received
    March 29, 2019
    Date of Event
    March 11, 2019
    Report Date
    May 2, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TWO PHOTOS AND EIGHT LOOSE 10ML SYRINGES WERE RECEIVED IN A CLEAR PLASTIC BAG AND VISUALLY EVALUATED. IT WAS OBSERVED FIVE HAD STOPPERS DETACHED AND STUCK IN THE BOTTOM OF THE BARREL FACING THE OPPOSITE DIRECTION. TWO WERE MISSING PLUNGER RODS, THREE HAD NO STOPPERS AND THREE STOPPERS WERE LOOSE IN THE BAG. FURTHERMORE, 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. POTENTIAL ROOT CAUSE FOR THE MISSING PLUNGER RODS AND MISSING STOPPERS IS ASSOCIATED WITH THE DETACHED STOPPERS. THE STOPPERS ARE WHAT HOLD THE PLUNGER ROD IN PLACE BY CREATING AN AIR TIGHT SEAL. THE DETACHED STOPPERS ARE ASSOCIATED WITH THE ASSEMBLY PROCESS. IF THE STOPPER DIAL BECOMES WORN, THEY WON'T LINE UP CORRECTLY WITH THE PLUNGER RODS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 9030991 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FORTY-SIX-THOUSAND-SEVEN-HUNDRED-FORTY-TWO BD¿ SYRINGE LL BNS HAD PLUNGER MISSING , OR HAD LOOSE STOPPERS INSIDE SYRINGES OR CARTON BOXES. CUSTOMER¿S VERBATIM: ¿ I HAVE RECEIVED NOTIFICATION THAT WE HAVE A TOTAL OF 46,742 PCS OF 301029 SYRINGES THAT ARE REJECTED FOR VARIOUS REASONS. 1) MISSING PLUNGER. 2) LOOSE PISTONS INSIDE THE SYRINGE. 3) LOOSE PISTONS IN THE CARTONS. THE LOT#¿S FOR THESE REJECTIONS IS 9030991. RECEIVED AGAINST POR PO 82113 & 82100. THANK YOU.¿

    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

    IT WAS REPORTED THAT FORTY-SIX-THOUSAND-SEVEN-HUNDRED-FORTY-TWO BD¿ SYRINGE LL BNS HAD PLUNGER MISSING , OR HAD LOOSE STOPPERS INSIDE SYRINGES OR CARTON BOXES. CUSTOMER¿S VERBATIM: ¿ I HAVE RECEIVED NOTIFICATION THAT WE HAVE A TOTAL OF (B)(4) PCS OF 301029 SYRINGES THAT ARE REJECTED FOR VARIOUS REASONS: MISSING PLUNGER; LOOSE PISTONS INSIDE THE SYRINGE; LOOSE PISTONS IN THE CARTONS. THE LOT#¿S FOR THESE REJECTIONS IS 9030991. RECEIVED AGAINST POR PO (B)(4). THANK YOU¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260306 BD SYRINGE LL BNS SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9030991

    Patients

    Seq Age Sex Outcome Treatment
    1 Other