BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE BD LUER-LOK SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 8601293 · Received May 10, 2019

    Report

    Report Number
    8041187-2019-00364
    Event Type
    Malfunction
    Date Received
    May 10, 2019
    Date of Event
    April 24, 2019
    Report Date
    April 26, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    UDI-DI
    30382903057802
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MEDICAL DEVICE TYPE: FMI/FMF. (B)(6). PMA / 510(K)#: K941562 (SYRINGE); K161170 (NEEDLE). INVESTIGATION SUMMARY: THE COMPLAINT IS UNCONFIRMED AS NO PHOTO / SAMPLES RECEIVED. DHR REVIEW WAS PERFORMED. THE BATGCH WAS BUILT WITH COMBO PACKAGING MACHINE IN AUGUST 2018. THERE WERE NO DAMAGE/DISTORTED BARREL REJECT AT THE OUTGOING INSPECTION. NO QUALITY NOTIFICATION WAS RAISED FOR PAST 12 MONTHS ON SIMILAR REPORTED DEFECTS. ROOT CAUSE DESCRIPTION: 1ML SYRINGE IS SUPPLIED BY BD CANNAN AND NOT MANUFACTURED IN TUAS. THE PACKAGING LINE WAS REVIEWED AND THERE IS NO PROCESS WHICH COULD HAVE CAUSED STOPPER SEPARATION FROM PLUNGER. BD CANNAN HAD BEEN NOTIFIED OF THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STOPPER SEPARATES FROM PLUNGER WITH A BD ECLIPSE¿ BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305780, BATCH NO: 8207169. IT WAS REPORTED THAT THE RUBBER STOPPER COMES APART FROM THE PLUNGER. DESCRIPTION: THE BLACK RUBBER TIP ON THE WHITE PUSHER INSIDE THE SYRINGE, COMES APART, AND RUBBER PIECE GETS STUCK ONCE RETRACTED, INSIDE THE SYRINGE. UNABLE TO DRAW UP MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391555 BD ECLIPSE BD LUER-LOK SYRINGE WITH DETACHABLE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE; PISTON SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) 8207169 30382903057802

    Patients

    Seq Age Sex Outcome Treatment
    1 Other