BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 15921961 · Received December 6, 2022

    Report

    Report Number
    1911916-2022-00705
    Event Type
    Malfunction
    Date Received
    December 6, 2022
    Date of Event
    November 10, 2022
    Report Date
    December 7, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051060
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT#: 1335483, MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2027, DEVICE MANUFACTURE DATE: 01-DEC-2021, MEDICAL DEVICE LOT#: 0022949, MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2025, DEVICE MANUFACTURE DATE: 22-JAN-2020. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED THERE APPEARS TO BE WHITE PAINT IN THE NEEDLE CAP. TO AID IN THE INVESTIGATION, FOUR SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THREE SAMPLES CAME WITH NO PACKAGING BLISTERS; THE LOT FOR THESE SAMPLES IS 'UNKNOWN.' ONE SAMPLE CAME IN A SEALED PACKAGING BLISTER FOR LOT 1335483. A VISUAL INSPECTION WAS PERFORMED AND ONE OF THE SAMPLES WITH NO PACKAGING BLISTER HAS AN EPOXY DRIP OVER ON THE NEEDLE HUB. THIS IS CONSIDERED AN IMPERFECTION AS IT DOES NOT AFFECT THE FIT, FORM OR FUNCTION OF THE MEDICAL DEVICE. THE OTHER THREE SAMPLES HAVE NO DEFECTS OR IMPERFECTIONS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305106, LOT NUMBER 1335483. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. HOWEVER, THE SYMPTOM REPORTED IS CONSIDERED AN IMPERFECTION AND NOT A DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD PRECISIONGLIDE¿ NEEDLES FROM LOTS: 1335483 AND 0022949 HAD WHITE, PAINT-LIKE FOREIGN MATTER FOUND ON THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE NOW HAD A 3RD COMPLAINT REGARDING THE SAME SUPPLY ITEM FROM THE SAME CLINIC. THE CLINIC HAS FOUND MORE OF THESE NEEDLES WITH WHAT APPEARS TO BE WHITE PAINT".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD PRECISIONGLIDE¿ NEEDLES FROM LOTS 1335483 AND 0022949 HAD WHITE, PAINT-LIKE FOREIGN MATTER FOUND ON THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE NOW HAD A 3RD COMPLAINT REGARDING THE SAME SUPPLY ITEM FROM THE SAME CLINIC. THE CLINIC HAS FOUND MORE OF THESE NEEDLES WITH WHAT APPEARS TO BE WHITE PAINT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2711683 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305106 INCORRECT ENTRY 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown