BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 30GA 1/2IN

    MDR report key: 12013968 · Received June 16, 2021

    Report

    Report Number
    1911916-2021-00564
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Date of Event
    May 18, 2021
    Report Date
    June 11, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: IT WAS REPORTED THE NEEDLE IS LUMPY WHEN INJECTING THE DRUG. TO AID IN THE INVESTIGATION, NINE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLES CAME WITH NO PACKAGING BLISTERS AND NO PLASTIC SHIELDS. A VISUAL INSPECTION WAS PERFORMED WITH A 30X MICROSCOPE. THE BEVELS AND ETCH WERE GOOD. NO DEFECTIVE GRIND OR HOOKS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305107, LOT NUMBER 0072060. 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: BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. 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: 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 30GA 1/2IN NEEDLE WAS LUMPY AND CAUSED THE PATIENT PAIN DURING INJECTION. THIS OCCURRED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE OPHTHALMOLOGIST USES D/N 30G FOR INTRAVITREAL INJECTION TO THE PATIENT, AND THE NEEDLE IS LUMPY WHEN INJECTING THE DRUG, MAKING IT DIFFICULT TO INJECT THE DRUG INTO THE PATIENT'S VITREOUS BODY, AND THE PATIENT COMPLAINS OF PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906777 NEEDLE 30GA 1/2IN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 0072060

    Patients

    Seq Age Sex Outcome Treatment
    1