BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE

    MDR report key: 8613803 · Received May 15, 2019

    Report

    Report Number
    1911916-2019-00474
    Event Type
    Malfunction
    Date Received
    May 15, 2019
    Date of Event
    April 30, 2019
    Report Date
    May 23, 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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: TWENTY-SEVEN (27) SHIELDED SAMPLES WERE RETURNED BY THE CUSTOMER FOR INVESTIGATION. ALL TWENTY-SEVEN (27) 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 (DHR) REVIEW WAS NOT ABLE TO BE PERFORMED ON THE BATCH ASSOCIATED WITH THIS INVESTIGATION AS THE BATCH NUMBER WAS NOT REPORTED. BD ACKNOWLEDGES THAT LIGHT WAS NOT ABLE TO PASS THROUGH THE RETURNED SAMPLES INDICATING THAT THE NEEDLES ARE CLOGGED / BLOCKED. THE ACCEPTABLE QUALITY LIMIT (AQL) FOR THIS NON-CONFORMANCE IS 0.10. AS THE BATCH NUMBER WAS NOT REPORTED IT CANNOT BE DETERMINED IF THESE TWENTY-SEVEN (27) OCCURRENCES WOULD EXCEED THE AQL.

    Description of Event or Problem · 0

    MATERIAL NO: 305106. BATCH NO: UNKNOWN. IT WAS REPORTED THAT DURING USE OF THE BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE THE NEEDLES WERE NOT ADMINISTERING THE MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVENT DESCRIPTION PER CUSTOMER'S EMAIL STATES, "NEEDLES NOT ADMINISTERING MEDICATION".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. 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. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    MATERIAL NO: 305106, BATCH NO: UNKNOWN. IT WAS REPORTED THAT DURING USE OF THE BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE THE NEEDLES WERE NOT ADMINISTERING THE MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVENT DESCRIPTION PER CUSTOMER'S EMAIL STATES, "NEEDLES NOT ADMINISTERING MEDICATION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403969 BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL UNKNOWN 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other