BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLES

    MDR report key: 15960143 · Received December 12, 2022

    Report

    Report Number
    1911916-2022-00723
    Event Type
    Malfunction
    Date Received
    December 12, 2022
    Date of Event
    November 21, 2022
    Report Date
    December 13, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    00382903051984
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY IT WAS REPORTED THERE WAS A FIBROUS MATERIAL INSIDE THE NEEDLE PACKAGING. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. THERE IS A DUST WITH LUBRICANT ADHERED TO THE NEEDLE AT 1/2" FROM THE NEEDLE TIP. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THE LUBRICATION APPLICATION STATION WAS NOT CLEANED PROPERLY INDUCING THE SYMPTOM REPORTED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305198, LOT NUMBER 2222150. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. VERIFICATION OF THE LUBRICATION APPLICATION PROCESS WAS PERFORMED. THE SETTINGS WERE CORRECT, AND THE CLEANLINESS OF THE EQUIPMENT WAS GOOD. THERE WERE NO RESIDUES OF DUST, OR ANY OTHER FOREIGN MATTER OBSERVED. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLES EXPERIENCED FOREIGN MATTER IN THE PACKAGING ON NEEDLE PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FIBER/ FIBEROUS MATERIAL IN THE PACKAGING ON NEEDLE PACK ONLY FOUND IN ONE SO FAR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLES EXPERIENCED FOREIGN MATTER IN THE PACKAGING ON NEEDLE PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FIBER/ FIBEROUS MATERAIL IN THE PACKAGING ON NEEDLE PACK ONLY FOUND IN ONE SO FAR

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386147 BD PRECISIONGLIDE¿ NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 2222150 00382903051984

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown