BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25 G X 1 IN. BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 6858714 · Received September 12, 2017

    Report

    Report Number
    1213809-2017-00113
    Event Type
    Malfunction
    Date Received
    September 12, 2017
    Date of Event
    August 18, 2017
    Report Date
    November 16, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    TWO OPENED AND PARTIALLY FILLED SHELF CARTONS WITH PACKAGED SAFETY GLIDE NEEDLES WERE RECEIVED BY BD CANAAN. THE SAMPLES WERE CONFIRMED TO BE FROM BATCH 6001842 (P/N 305916) AND WERE VISUALLY EVALUATED. BOX #1: THE BOX CONTAINED 21 SEALED PACKAGED SAFETY GLIDE NEEDLES: 14 WERE 1" IN LENGTH, WHILE 7 WERE 5/8" IN LENGTH. BOX #2: THE BOX CONTAINED 50 SEALED PACKAGED SAFETY GLIDE NEEDLES: 34 WERE 1" IN LENGTH, WHILE 16 WERE 5/8" IN LENGTH. QUALITY HAS PREVIOUSLY REVIEWED, EVALUATED AND INVESTIGATED THIS FAILURE MODE. SITUATIONAL ANALYSIS (B)(4) AND (B)(4). NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 1 OUT OF EVERY 10, 25 G X 1 IN. BD SAFETYGLIDE¿ NEEDLE ARE SHORTER THAN THEY ARE LABELED. NO REPORTED MEDICAL INTERVENTION OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637670 25 G X 1 IN. BD SAFETYGLIDE¿ NEEDLE HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 6001842

    Patients

    Seq Age Sex Outcome Treatment
    1 Other