BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 9309167 · Received November 12, 2019

    Report

    Report Number
    1911916-2019-01183
    Event Type
    Malfunction
    Date Received
    November 12, 2019
    Date of Event
    October 15, 2019
    Report Date
    December 4, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051114
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE PHOTO WAS PROVIDED. IT SHOWS A NEEDLE ASSEMBLY CONNECTED TO A SYRINGE. THE NEEDLE ASSEMBLY HAS THE NEEDLE BENT AND GOES THROUGH THE PLASTIC SHIELD. IT IS LIKELY THAT THE NEEDLE WAS BENT DURING THE NEEDLE ASSEMBLY PROCESS AND WHEN THE SHIELD WAS PLACED, THE NEEDLE PIERCED THE SHIELD. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES.

    Description of Event or Problem · 0

    MATERIAL NO.: 305111, BATCH NO.: 9093862. IT WAS REPORTED THAT BEFORE USE OF THE BD PRECISIONGLIDE¿ NEEDLE THE NEEDLE WAS STICKING THROUGH THE SHIELD RESULTING IN A NEEDLE STICK TO THE USER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE WAS STICKING THROUGH THE SHIELD CAUSING A NEEDLE STICK TO THE USER. THE CUSTOMER STATED THAT THE NEEDLE WASN'T USED. THEY ALSO STATED THAT THIS IS THE ONLY NEEDLE THEY HAVE SEEN STICKING THROUGH THE CAP AND THE FIRST TIME IT HAS HAPPENED.

    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.: 305111, BATCH NO.: 9093862. IT WAS REPORTED THAT BEFORE USE OF THE BD PRECISIONGLIDE¿ NEEDLE THE NEEDLE WAS STICKING THROUGH THE SHIELD RESULTING IN A NEEDLE STICK TO THE USER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE WAS STICKING THROUGH THE SHIELD CAUSING A NEEDLE STICK TO THE USER. THE CUSTOMER STATED THAT THE NEEDLE WASN'T USED. THEY ALSO STATED THAT THIS IS THE ONLY NEEDLE THEY HAVE SEEN STICKING THROUGH THE CAP AND THE FIRST TIME IT HAS HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103291 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SYRINGE AND NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 9093862 30382903051114

    Patients

    Seq Age Sex Outcome Treatment
    1 Other