BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE

    MDR report key: 8569196 · Received May 1, 2019

    Report

    Report Number
    1911916-2019-00425
    Event Type
    Malfunction
    Date Received
    May 1, 2019
    Date of Event
    April 10, 2019
    Report Date
    May 8, 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
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THREE (3) SAMPLES WERE RECEIVED FROM THE CUSTOMER FOR INVESTIGATION. TWO (2) OF THE RETURNED SAMPLES WERE FOUND TO HAVE BENT NEEDLES AND THE THIRD (3RD) SAMPLE WAS FOUND TO BE CLOGGED AS LIGHT WAS NOT ABLE TO PASS THROUGH THE SAMPLE. A BENT NEEDLE COULD BE CAUSED DURING THE ASSEMBLY PROCESS BEFORE THE NEEDLE IS SHIELDED. 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

    IT WAS REPORTED THAT DURING USE OF THE BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC THE NEEDLE NEEDLES ARE CLOGGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:MATERIAL NO.: 305106 BATCH NO.: UNKNOWN. IT WAS REPORTED THE NEEDLES ARE CLOGGING. PER (B)(4) VERBATIM: DISTRIBUTOR REP CALLED TO REPORT THAT AT A FACILITY THEY HAVE BEEN EXPERIENCING CLOGGING OF THE NEEDLES, 5-6 DAILY. THEY GET THEIR NEEDLES FROM 3 PROVIDERS. LOT NUMBER UNAVAILABLE B/C THEY DO NOT KEEP THE BOXES AT THE FACILITY.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EVALUATED BY MFR: 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

    IT WAS REPORTED THAT DURING USE OF THE BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC THE NEEDLE NEEDLES ARE CLOGGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:MATERIAL NO.: 305106, BATCH NO.: UNKNOWN. IT WAS REPORTED THE NEEDLES ARE CLOGGING. PER (B)(4) VERBATIM: DISTRIBUTOR REP CALLED TO REPORT THAT AT A FACILITY THEY HAVE BEEN EXPERIENCING CLOGGING OF THE NEEDLES, ~ 5-6 DAILY. THEY GET THEIR NEEDLES FROM 3 PROVIDERS. LOT NUMBER UNAVAILABLE B/C THEY DO NOT KEEP THE BOXES AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361290 BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 8324761 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other