BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE

    MDR report key: 8945942 · Received August 29, 2019

    Report

    Report Number
    1911916-2019-00884
    Event Type
    Malfunction
    Date Received
    August 29, 2019
    Date of Event
    August 5, 2019
    Report Date
    September 10, 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

    H.6. INVESTIGATION: ONE (1) SAMPLE WAS PROVIDED BY THE CUSTOMER FOR INVESTIGATION. THE RETURNED SAMPLE WAS VISUALLY EXAMINED USING 30X MAGNIFICATION LOOKING FOR POINT DAMAGE OR DEFECTS AS THE CUSTOMER REPORTED CLOSED BEVEL TIPS. THE RETURNED SAMPLE WAS FOUND TO NOT HAVE ANY DAMAGE, THE BEVELS WERE GOOD AND THE ETCH WAS GOOD WITH NO DEFECTIVE GRIND OR HOOKS OBSERVED. THE RETURNED SAMPLE WAS THEN VISUALLY EXAMINED FOR CLOGS AS THE CUSTOMER REPORTED THAT IT WOULD NOT ASPIRATE MEDICATION AND IT WAS OBSERVED THAT THE SAMPLE WAS CLOGGED AS LIGHT WAS NOT ABLE TO PASS THROUGH THE SAMPLE. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. 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. BD ACKNOWLEDGES THAT THE RETURNED NEEDLE WAS CLOGGED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    MATERIAL NO. 305106; BATCH NO. 8324761. IT WAS REPORTED THAT DURING USE OF THE BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE SOME NEEDLES HAD CLOSED BEVEL TIPS AND DID NOT ASPIRATE MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER CALLED STATING THAT SOME OF THE NEEDLES HAS THE BEVEL TIP CLOSED UP, AND THEY DO NOT ASPIRATE MEDICATION.

    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. 8324761. IT WAS REPORTED THAT DURING USE OF THE BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE SOME NEEDLES HAD CLOSED BEVEL TIPS AND DID NOT ASPIRATE MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER CALLED STATING THAT SOME OF THE NEEDLES HAS THE BEVEL TIP CLOSED UP, AND THEY DO NOT ASPIRATE MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740867 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