BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE NEEDLE

    MDR report key: 11091321 · Received December 29, 2020

    Report

    Report Number
    1911916-2020-01144
    Event Type
    Malfunction
    Date Received
    December 29, 2020
    Date of Event
    June 12, 2020
    Report Date
    December 16, 2020
    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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S ADDRESS IS UNKNOWN. UNKNOWN, (B)(6) HAS BEEN USED AS A PLACEHOLDER BASED ON THE REPORTED PHONE AREA CODE. (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305106 AND LOT NUMBER 9193522. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED DEFECT. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. ONE PHOTO SHOWS SIX NEEDLE ASSEMBLIES WITH NO PACKAGING BLISTER AND WITH THE PLASTIC SHIELD. THREE OF THEM HAVE THE NEEDLE HUB A LIGHT PINK COLOR AND THE OTHER THREE HAVE A DARK PINK COLOR. THERE IS A PACKAGING BLISTER TOP WEB NEXT TO THEM FROM "BVI BEAVER" COMPANY. THE OTHER PHOTO SHOWS THREE NEEDLE ASSEMBLIES WITH NO PACKAGING BLISTER OR PLASTIC SHIELD. THERE IS A RULER NEXT TO THEM CONFIRMING THEY ARE 1/2" LONG. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION AND WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. HOWEVER, THE PHOTOS RECEIVED SHOW A PACKAGING BLISTER TOP WEB FROM BVI BEAVER COMPANY. THE SOURCE OF THESE PRODUCTS IS UNKNOWN. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE SOURCE OF THESE PRODUCTS IS UNKNOWN. RATIONALE: FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DIFFERENT NEEDLES WERE FOUND IN THE PACK OF BD PRECISIONGLIDE¿ NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DIFFERENT NEEDLES PLACED IN THE PACK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555923 BD PRECISIONGLIDE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305106 9193522 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1