BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD 5 ML SYRINGE

    MDR report key: 11963746 · Received June 9, 2021

    Report

    Report Number
    2243072-2021-01647
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Date of Event
    May 6, 2021
    Report Date
    June 1, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. INITIAL REPORTER PHONE #: (B)(6). INITIAL REPORTER FACILITY NAME: (B)(6). DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: AS NO PHYSICAL SAMPLE, PICTURE SAMPLE, OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. 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. INVESTIGATION CONCLUSION: MATERIAL NUMBER AND BATCH NUMBER IS UNKNOWN; REVIEWS COULD NOT BE PERFORMED. BASED ON LIMITED INFORMATION AVAILABLE AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS TO OBTAIN. NO SAMPLE WAS PROVIDED BY THE CUSTOMER AFTER MULTIPLE REQUEST.  CAPA IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT LEAST ONE UNSPECIFIED BD 5 ML SYRINGE EXPERIENCED LEAKAGE, AND DIFFICULT PLUNGER MOVEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BD SYRINGE 5 ML 70X30 - CUSTOMER BOUGHT 5 BD SYRINGES FOR APPLICATION OF DEXA-CITONEURIN, 3 SYRINGES WERE DEFECTIVE. PROFESSIONAL MENTIONS THAT WHEN EXTRACTING MEDICINE FROM THE AMPOULE FOR SYRINGE, IN THE APPLICATION, THERE WAS RESISTANCE / LOCKING IN THE PLUNGER OF THE SAME, CAUSING LEAKAGE BY THE NEEDLE - BY THE FRONT OF THE SYRINGE. SHE MENTIONED THAT APPROXIMATELY 3 ML OF THE MEDICINE LEAKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862774 UNSPECIFIED BD 5 ML SYRINGE SYRINGE FMF BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1