BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGE

    MDR report key: 8428184 · Received March 18, 2019

    Report

    Report Number
    9614033-2019-00126
    Event Type
    Malfunction
    Date Received
    March 18, 2019
    Date of Event
    February 27, 2019
    Report Date
    March 22, 2019
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER PICTURES ARE RECEIVED BUT NO PHYSICAL SAMPLE IS RECEIVED FOR AN ANALYSIS MORE COMPLEX. SAMPLE IS REQUIRED FOR COMPLETE AND DETAILED ANALYSIS TO DETERMINE WHETHER OR NOT FOREIGN MATTER IS ATTRIBUTABLE TO THE MANUFACTURING PROCESS. WHEN TESTING THE RETENTION SAMPLES, NO FOREIGN PARTICLE WAS FOUND SUCH AS THE ONE THE CUSTOMER REPORTS, SO THE RESULTS ARE COMPLIANT. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DIRT-LIKE FOREIGN MATTER WAS FOUND WHERE THE BD PLASTIPAK¿ SYRINGE CONNECTED TO THE NEEDLE AFTER USE. AS REPORTED BY THE CUSTOMER, TRANSLATED FROM SPANISH TO ENGLISH, "A COMPLAINT OF THE CODE (B)(4) WITH LOT 7170732. THE PRODUCT HAS A SPOT ON THE PART WHERE THE NEEDLE IS CONNECTED, AND THEY NOTICED IT AFTER USING THE PRODUCT, THE CUSTOMER (WHO IS AN END USER) WANTS TO KNOW IF THERE IS ANY RISK OF HEALTH DUE TO HAVING USED THE PRODUCT WELL. (PHOTOS ATTACHED)"

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 DIRT-LIKE FOREIGN MATTER WAS FOUND WHERE THE BD PLASTIPAK¿ SYRINGE CONNECTED TO THE NEEDLE AFTER USE. AS REPORTED BY THE CUSTOMER, TRANSLATED FROM SPANISH TO ENGLISH, "A COMPLAINT OF THE CODE (B)(4) WITH LOT 7170732. THE PRODUCT HAS A SPOT ON THE PART WHERE THE NEEDLE IS CONNECTED, AND THEY NOTICED IT AFTER USING THE PRODUCT, THE CUSTOMER (WHO IS AN END USER) WANTS TO KNOW IF THERE IS ANY RISK OF HEALTH DUE TO HAVING USED THE PRODUCT WELL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224138 BD PLASTIPAK¿ SYRINGE SYRINGE WITH NEEDLE FMI BECTON DICKINSON DE MEXICO 7170732

    Patients

    Seq Age Sex Outcome Treatment
    1 Other