BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK SYRINGE

    MDR report key: 8519011 · Received April 16, 2019

    Report

    Report Number
    1920898-2019-00356
    Event Type
    Malfunction
    Date Received
    April 16, 2019
    Date of Event
    March 25, 2019
    Report Date
    April 3, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (2) LOOSE 1CC, 12.7MM SYRINGES. CUSTOMER STATES THAT THE SCALE MARKING IS LIGHT. BOTH RETURNED SYRINGES WERE EXAMINED AND BOTH EXHIBITED CLEARLY PRINTED SCALE MARKINGS ON THE BARRELS WITH NO OBSERVED DEFECTS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7296924. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200723839, 200723843] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WERE THREE (3) NOTIFICATIONS [200723264, 200723290, 200723263] NOTED FOR SCRATCHED PRINT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD PLASTIPAK¿ SYRINGES HAD LIGHTLY PRINTED SCALE MARKINGS, FOUND BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "SCALE MARKING LIGHT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310155 BD PLASTIPAK SYRINGE SYRINGE FMF BD MEDICAL - DIABETES CARE 7296924

    Patients

    Seq Age Sex Outcome Treatment
    1 Other