BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ NEEDLE 1/2 IN. SINGLE USE, STERILE, 30 G

    MDR report key: 15987405 · Received December 15, 2022

    Report

    Report Number
    1911916-2022-00741
    Event Type
    Malfunction
    Date Received
    December 15, 2022
    Date of Event
    November 23, 2022
    Report Date
    November 30, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    50382903051064
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: IT WAS REPORTED THE NEEDLES ARE NOT GLIDING PROPERLY AND ARE CLOGGED. TO AID IN THE INVESTIGATION, TWO HUNDRED TWENTY-FOUR SAMPLES IN SEALED PACKAGING BLISTERS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. EIGHTY SAMPLES WERE SELECTED RANDOMLY. A VISUAL INSPECTION WAS PERFORMED. FIRST, WITH A 10X MAGNIFIER LENS, THEN WITH A 30X MICROSCOPE. THERE WAS NO DAMAGE, DEFECTIVE GRIND OR HOOKS OBSERVED. THE BEVELS AND ETCH WERE GOOD. EACH OF THE SAMPLES SELECTED WERE THEN CONNECTED TO A SYRINGE WITH SALINE SOLUTION. ALL THE SAMPLES EXPELLED THE SOLUTION WITH A NORMAL FLOW. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305106, LOT NUMBER 2087106. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED, AND A PROBABLE ROOT CAUSE COULD NOT BE OFFERED. 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 · 0

    IT WAS REPORTED BY THE CUSTOMER THAT 3 OF THE BD¿ NEEDLE 1/2 IN. SINGLE USE, STERILE, 30 G DO NOT GLIDE AS IT SHOULD BE DURING INTRAVITREAL ADMINISTRATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO OUR PROVIDER (RETINA SPECIALIST) SOME NEEDLE DOESN¿T GLIDE AS IT SHOULD BE DURING INTRAVITREAL ADMINISTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440117 BD¿ NEEDLE 1/2 IN. SINGLE USE, STERILE, 30 G HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 2087106 50382903051064

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown