BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP

    MDR report key: 8488503 · Received April 5, 2019

    Report

    Report Number
    1213809-2019-00417
    Event Type
    Malfunction
    Date Received
    April 5, 2019
    Date of Event
    March 20, 2019
    Report Date
    May 23, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE BOX AND THREE BAGS WITH A TOTAL OF 644 SYRINGES (B)(4). WERE RECEIVED AND EVALUATED. THREE OF THE PACKAGES WERE OPENED AND EMPTY WITH THE REST IN FULLY SEALED BLISTER PACKS. 182 WERE CONFIRMED TO BE FROM BATCH #4119979, 202 WERE CONFIRMED TO BE FROM BATCH #8287811, 200 WERE CONFIRMED TO BE FROM BATCH #8287818, 60 WERE CONFIRMED TO BE FROM BATCH #8212690 AND ONE EMPTY PACKAGE FROM BATCH #8244746. ALL THE SAMPLES WERE VISUALLY INSPECTED, AND THE SILICONE OBSERVED WAS THE NORMAL AND EXPECTED AMOUNT PER PRODUCT SPECIFICATION. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. ROOT CAUSE NOT DEFINED SINCE DEFECTS WERE NOT CONFIRMED IN SAMPLES RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP HAD FOREIGN MATTER IN THE SYRINGE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309657 BATCH NO.: 8212690, 4119979, 8287818. IT WAS REPORTED THERE IS A GRIMY LIQUID ON THE INSIDE OF THE BARREL OF THE SYRINGE. VERBATIM: THERE IS A GRIMY LIQUID ON THE INSIDE OF THE BARREL OF THE SYRINGE. IT RESEMBLES LIQUID SILICONE. IT IS MUCH MORE VISCOUS THAN WATER. THE VOLUME OF THE LIQUID IS OFTEN ENOUGH TO CREATE A 'BUBBLE' WHEN PLUNGING AIR FROM THE SYRINGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8212690; MEDICAL DEVICE EXPIRATION DATE: 2023-07-31; DEVICE MANUFACTURE DATE: 2018-07-31; MEDICAL DEVICE LOT #: 4119979; MEDICAL DEVICE EXPIRATION DATE: 2019-03-31; DEVICE MANUFACTURE DATE: 2014-04-29; MEDICAL DEVICE LOT #: 8287818; MEDICAL DEVICE EXPIRATION DATE: 2023-09-30; DEVICE MANUFACTURE DATE: 2018-10-14. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP HAD FOREIGN MATTER IN THE SYRINGE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309657, BATCH NO.: 8212690, 4119979, 8287818. IT WAS REPORTED THERE IS A GRIMY LIQUID ON THE INSIDE OF THE BARREL OF THE SYRINGE. VERBATIM: THERE IS A GRIMY LIQUID ON THE INSIDE OF THE BARREL OF THE SYRINGE. IT RESEMBLES LIQUID SILICONE. IT IS MUCH MORE VISCOUS THAN WATER. THE VOLUME OF THE LIQUID IS OFTEN ENOUGH TO CREATE A 'BUBBLE' WHEN PLUNGING AIR FROM THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282801 BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other