BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 30X1/2 RB

    MDR report key: 9637358 · Received January 28, 2020

    Report

    Report Number
    1911916-2020-00061
    Event Type
    Malfunction
    Date Received
    January 28, 2020
    Date of Event
    January 6, 2020
    Report Date
    January 15, 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
    OK, 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: 62 SAMPLES WERE RECEIVED. THEY CAME IN A SHELF BOX 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. 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 1ST 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¿) AND 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 THE CUSTOMER NOTICED THE NEEDLES WERE 1 INCH IN SIZE INSTEAD OF 1/2 INCH AS STATED ON THE BOX. MATERIAL NO: 305106 BATCH NO: 9193522. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: CALLER OPENED THE BOX OF NEEDLES AND NOTICED THE NEEDLES WERE 1 INCH IN SIZE INSTEAD OF 1/2 INCH AS STATED ON THE BOX. THEY STATED THERE WAS ONLY ONE BOX AFFECTED AND IT IS AVAILABLE TO BE RETURNED FOR EVALUATION. SOME OF THE NEEDLES HAVE BEEN USED ALREADY AND NO ADVERSE EVENTS OR SAFETY ISSUES WERE REPORTED BECAUSE OF THIS DEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103347 NEEDLE 30X1/2 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305106 9193522 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other