BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE NEEDLE

    MDR report key: 9649389 · Received January 30, 2020

    Report

    Report Number
    1911916-2020-00078
    Event Type
    Malfunction
    Date Received
    January 30, 2020
    Date of Event
    January 14, 2020
    Report Date
    January 21, 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
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: 751 SAMPLES WERE RECEIVED. THEY CAME IN 8 SHELF BOXES IN SEALED PACKAGING BLISTER. ALL HAVE 1¿ NEEDLE INSTEAD OF ½¿. 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. 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. 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: THIS IS THE 2ND COMPLAINT FOR LOT # 9193522 FOR THIS TYPE OF DEFECT OR SYMPTOM. 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. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PRECISIONGLIDE¿ NEEDLE HAD THE WRONG LENGTH NEEDLE IN THE BOX. THIS OCCURRED ON 751 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305106 BATCH NO. 9193522. IT WAS REPORTED THAT THE WRONG LENGTH NEEDLE IS IN THE BOX, 30 GAUGE 1 INCH NEEDLE IS IN THE BOX LABELED 30 GAUGE .5 INCH. WE HAVE FOUND 751 EA OF THE FOLLOWING NEEDLES ARE INCORRECTLY LABELED. ISSUE: THE WRONG LENGTH NEEDLE IS IN THE BOX. A 30 GAUGE 1 INCH NEEDLE IS IN THE BOX LABELED 30 GAUGE .5 INCH. (B)(6): RCVD AN EMAIL FROM THE CUSTOMER PROVIDING THE FOLLOWING INFORMATION: WHAT DATE WERE THE WRONG LENGTH NEEDLES IDENTIFIED? (B)(6) 2020. WERE THE NEEDLES IDENTIFIED BEFORE, DURING, OR AFTER PATIENT USE? BEFORE. ARE SAMPLES AVAILABLE FOR INVESTIGATION? IF YES, I WILL PROVIDE YOU A PREPAID SHIPPING LABEL. YES, WE HAVE 751 EA TO RETURN FROM THAT LOT#.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113597 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