BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 30X1/2 RB

    MDR report key: 12375571 · Received August 26, 2021

    Report

    Report Number
    1911916-2021-00886
    Event Type
    Malfunction
    Date Received
    August 26, 2021
    Date of Event
    July 28, 2021
    Report Date
    August 19, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    00382903051069
    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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) USA HAS BEEN USED AS A DEFAULT. INVESTIGATION SUMMARY: IT WAS REPORTED BY THE MEDICAL PROFESSIONAL, THE NEEDLE WAS DULL AND THE PHYSICIAN WAS UNABLE TO INJECT THE MEDICATION INTO THE PATIENT'S EYE. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. EACH PHOTO SHOWS A NEEDLE ASSEMBLY WHERE THE NEEDLE TIP APPEARS TO BE NOT SHARP ENOUGH. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305106, LOT NUMBER 9162858. 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. INVESTIGATION CONCLUSION: 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. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED, BUT WITHOUT THE PHYSICAL 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 30X1/2 RB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE MEDICAL PROFESSIONAL, THE NEEDLE WAS DULL AND THE PHYSICIAN WAS UNABLE TO INJECT THE MEDICATION INTO THE PATIENT'S EYE. VERBATIM: ON (B)(6) 2021, THE REPORTER CONTACTED MEDICAL INFORMATION REQUESTING REPLACEMENT FOR ONE EYLEA VIAL. HE STATED THAT THE NEEDLE WAS DULL AND THE PHYSICIAN WAS UNABLE TO INJECT THE MEDICATION INTO THE PATIENT'S EYE. THE PATIENT WAS GIVEN EYLEA USING ANOTHER VIAL THAT WAS DRAWN UP. THE REPORTER WAS ADVISED TO RETAIN COMPONENTS FOR RETRIEVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271815 NEEDLE 30X1/2 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 9162858 00382903051069

    Patients

    Seq Age Sex Outcome Treatment
    1