BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ SYRINGE AND NEEDLE

    MDR report key: 9370733 · Received November 25, 2019

    Report

    Report Number
    1213809-2019-01181
    Event Type
    Malfunction
    Date Received
    November 25, 2019
    Date of Event
    October 18, 2019
    Report Date
    January 14, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059066
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE 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. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    MATERIAL NO. 305906; BATCH NO. 9189700. IT WAS REPORTED THAT BEFORE USE OF THE BD SAFETYGLIDE¿ SYRINGE AND NEEDLE THE PLUNGER BENT INSIDE THE PACKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BENT PLUNGER INSIDE PACKAGE."

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: K980987(SYRINGE); K951254 (NEEDLE). 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

    MATERIAL NO. 305906 BATCH NO. 9189700. IT WAS REPORTED THAT BEFORE USE OF THE BD SAFETYGLIDE¿ SYRINGE AND NEEDLE THE PLUNGER BENT INSIDE THE PACKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BENT PLUNGER INSIDE PACKAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1168179 BD SAFETYGLIDE¿ SYRINGE AND NEEDLE PISTON SYRINGE, HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 9189700 30382903059066

    Patients

    Seq Age Sex Outcome Treatment
    1 Other