BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ HYPODERMIC SYRINGE WITH NEEDLE

    MDR report key: 7071879 · Received November 30, 2017

    Report

    Report Number
    3003916417-2017-00094
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    November 8, 2017
    Report Date
    December 21, 2017
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE BATCH RECORD, QUALITY NOTIFICATION AND MAINTENANCE RECORDS WERE ANALYZED FOR CATALOG 990628, LOT NUMBER 3147192, AND NO DEVIATION WAS FOUND. WITHOUT SAMPLES OR PHOTOS IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE. COMPLAINT WAS NOT CONFIRMED. BASED ON NO SAMPLE/NO PHOTO, THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE. 00 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: THE BATCH RECORD, QUALITY NOTIFICATION AND MAINTENANCE RECORD WERE VERIFIED AND NO DEVIATION WAS FOUND. WITHOUT SAMPLES OR PHOTOS IT WAS NOT POSSIBLE DETERMINE THE ROOT CAUSE. COMPLAINT NOT CONFIRMED. ROOT CAUSE DESCRIPTION: WITHOUT SAMPLES OR PHOTOS IT WAS NOT POSSIBLE DETERMINE THE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD PLASTIPAK¿ HYPODERMIC SYRINGE WITH NEEDLE DURING USE MALFUNCTIONED AS THE PLUNGER WAS REPORTED WITH RESISTANCE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852243 BD PLASTIPAK¿ HYPODERMIC SYRINGE WITH NEEDLE INTERVASCULAR CATHETER FMF BECTON DICKINSON IND. CIRURGICAS LTDA 3147192

    Patients

    Seq Age Sex Outcome Treatment
    1 Other