BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 10ML SYRINGE LUER-LOK TIP

    MDR report key: 9124397 · Received September 26, 2019

    Report

    Report Number
    1213809-2019-00974
    Event Type
    Malfunction
    Date Received
    September 26, 2019
    Date of Event
    August 20, 2019
    Report Date
    November 7, 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
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE LOOSE 10ML SYRINGE WAS RECEIVED AND EVALUATED UNDER 2.5X MAGNIFICATION. NO WHITE PARTICLE WAS FOUND INSIDE THE SYRINGE. THE PHOTO RECEIVED DISPLAYED TWO LOOSE 60ML SYRINGES, WHICH WERE NOT MANUFACTURED AT THE CANAAN FACILITY. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT. NO DEFECT WAS OBSERVED. 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. 301029 BATCH NO. 9142635 IT WAS REPORTED THAT BEFORE USE OF THE BD 10ML SYRINGE LUER-LOK¿ TIP A WHITE PARTICLE WAS FOUND INSIDE THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING INSPECTION A WHITE PARTICLE FOUND INSIDE SYRINGE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO. 301029. BATCH NO. 9142635. IT WAS REPORTED THAT BEFORE USE OF THE BD 10ML SYRINGE LUER-LOK¿ TIP A WHITE PARTICLE WAS FOUND INSIDE THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING INSPECTION A WHITE PARTICLE FOUND INSIDE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920659 BD 10ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9142635

    Patients

    Seq Age Sex Outcome Treatment
    1 Other