BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 RB

    MDR report key: 11319181 · Received February 11, 2021

    Report

    Report Number
    1911916-2021-00112
    Event Type
    Malfunction
    Date Received
    February 11, 2021
    Date of Event
    November 20, 2020
    Report Date
    February 4, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    00382903051960
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) USA HAS BEEN USED AS A DEFAULT. THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 12 JANUARY, 2021. MEDWATCH REPORT # MW5098453. REPORT SOURCE OTHER: MEDWATCH REPORT (B)(4). INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305196 AND LOT NUMBER 0051422. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. INVESTIGATION CONCLUSION: WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THIS PRODUCT AND SYMPTOM. ROOT CAUSE DESCRIPTION: WITH NO SAMPLE ANALYSIS A PROBABLE ROOT CAUSE COULD NOT BE OFFERED. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE 18X1-1/2 RB DISLODGED FROM THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305196, BATCH NO.: 0051422. IT WAS REPORTED THAT THE NEEDLE DISLODGED FROM THE HUB WHILE WITHDRAWING THE NEEDLE FROM THE VIAL. PER ATTACHED MEDWATCH REPORT: AN 18 GAUGE NEEDLE DISLODGED FROM THE HUB WHILE WITHDRAWING THE NEEDLE FROM A VIAL, NO INJURY OCCURRED. THE NEEDLE USED WAS A BD PRECISIONGLIDE, 118G X 1 11/2 (1.2MM X 40MM), REF 305196, LOT 0051422 EXP 2025-03-31. BECTON DICKINSON AND COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214736 NEEDLE 18X1-1/2 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 0051422 00382903051960

    Patients

    Seq Age Sex Outcome Treatment
    1