BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 9700382 · Received February 12, 2020

    Report

    Report Number
    1911916-2020-00139
    Event Type
    Malfunction
    Date Received
    February 12, 2020
    Date of Event
    January 30, 2020
    Report Date
    February 3, 2020
    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
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: TWO PHOTOS WERE PROVIDED. ONE SHOWS TWO NEEDLE ASSEMBLIES; ONE WITH A ½¿ NEEDLE LONG AND THE OTHER WITH A 1¿ NEEDLE LONG. THE OTHER PHOTO SHOWS THE TOP WEB PACKAGING CONFIRMING THE SAME LOT# 9193522 AND DESCRIPTION OF THE PRODUCT. THE PREVIOUS BATCH WAS VERIFIED CONFIRMING IT WAS FOR THE SAME PRODUCT 305106- 30 X ½¿. BOTH HAVE THE SAME PLASTIC HUB COLOR AND PLASTIC SHIELD TYPE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. 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. INVESTIGATION CONCLUSION: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE WITH THE PHOTOS PROVIDED. THIS IS THE 2ND COMPLAINT FOR LOT # 9193522 FOR THIS TYPE OF DEFECT OR SYMPTOM. PREVIOUS COMPLAINT (B)(4). THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. ROOT CAUSE DESCRIPTION: IT IS LIKELY THAT ONE BAG WITH THE 305128 (30X1¿) WAS MIXED IN THE GAYLORD OF THE 305106 (30X ½¿). IT WAS NOT DETECTED AT THE MULTIVAC PACKAGING PROCESS BY PERSONNEL. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "30GX1 ½" NEEDLES WERE FOUND MIXED INTO THE BOX OF BD PRECISIONGLIDE¿ NEEDLES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE RECEIVED A BOX OF 30G AND ½ NEEDLES AND EVERY OTHER ONE IS 30G AND 1 AND ½." "MIXED IN WITH THE 30GX ½ WERE RANDOM 30GX1 ½ . THEY WERE ALL LABELED INDIVIDUALLY 30GX ½."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166939 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305106 9193522 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other