BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE

    MDR report key: 8619638 · Received May 17, 2019

    Report

    Report Number
    1911916-2019-00487
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    April 30, 2019
    Report Date
    June 3, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051060
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THREE (3) SHIELDED SAMPLES WERE RETURNED BY THE CUSTOMER FOR INVESTIGATION. THE SAMPLES WERE VISUALLY EXAMINED AND IT WAS FOUND THAT LIGHT WAS NOT ABLE TO PASS THROUGH THE SAMPLES INDICATING THAT THEY WERE CLOGGED. FOREIGN MATERIAL (FM) CAN BE INTRODUCED TO THE FLUID PATH DURING THE MANUFACTURING PROCESS WHICH COULD CAUSE THE NEEDLE TO BECOME CLOGGED. ALL PRODUCT IS AUTOMATICALLY CHECKED FOR CLOGGED NEEDLES DURING THE PRODUCTION PROCESS. 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: 305106 BATCH NO: 8143647. IT WAS REPORTED THAT DURING USE OF THE BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE THE DOCTOR WAS TRYING TO PUSH LIQUID THROUGH THE NEEDLE AND LIQUID WOULD NOT GO THROUGH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PER CUSTOMER EMAIL: CALL RECEIVED FROM CUSTOMER DR.OFFICE ABOUT ITEM # 305106 WITH NO HOLES IN THE NEEDLES?

    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: 305106, BATCH NO: 8143647. IT WAS REPORTED THAT DURING USE OF THE BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE THE DOCTOR WAS TRYING TO PUSH LIQUID THROUGH THE NEEDLE AND LIQUID WOULD NOT GO THROUGH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PER CUSTOMER EMAIL: CALL RECEIVED FROM CUSTOMER DR. OFFICE ABOUT ITEM # 305106 WITH NO HOLES IN THE NEEDLES?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411836 BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 8143647 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other