BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ PLASTIPAK HYPODERMIC SYRINGE WITH NEEDLE

    MDR report key: 8186852 · Received December 20, 2018

    Report

    Report Number
    3003916417-2018-00353
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Date of Event
    May 22, 2018
    Report Date
    December 27, 2018
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PICTURE RELATED WITH THE OCCURRENCE WAS RECEIVED FOR ANALYSIS. IT WAS CONFIRMED NEEDLE HUB DAMAGED. DHR REVIEW: 7173878- IT WAS VERIFIED THE BATCH RECORD AND THE MANUFACTURING DATE WAS JULY 04TH ¿ 07TH, 2017. THE PROCESS INSPECTIONS WERE PERFORMED AND NO RECORDS OF THIS INCIDENT WERE FOUND. THE CURRENT CONTROLS AT MANUFACTURING PROCESS TO DETECT THE INCIDENT, ARE PERFORMED BY GENERAL VISUAL INSPECTION EACH 02 HOURS AT 36 PARTS AT MANUFACTURING PROCESS. 7150906 IT WAS VERIFIED THE BATCH RECORD AND THE MANUFACTURING DATE WAS JUNE 20TH ¿ 22ND, 2017. THE PROCESS INSPECTIONS WERE PERFORMED AND NO RECORDS OF THIS INCIDENT WERE FOUND. THE CURRENT CONTROLS AT ASSEMBLY PROCESS TO DETECT THE INCIDENT, ARE PERFORMED BY LEAKAGE INSPECTION EACH 02 HOURS AT 50 PARTS AT ASSEMBLY PROCESS. 7179740- IT WAS VERIFIED THE BATCH RECORD AND THE MANUFACTURING DATE WAS JULY 01ST ¿ 05TH, 2017. THE PROCESS INSPECTIONS WERE PERFORMED AND NO RECORDS OF THIS INCIDENT WERE FOUND. THE CURRENT CONTROLS AT MANUFACTURING PROCESS TO DETECT THE INCIDENT, ARE PERFORMED BY LEAKAGE INSPECTION EACH 02 HOURS AT 50 PARTS AT ASSEMBLY PROCESS. QN REVIEW: NO QUALITY NOTIFICATIONS RELATED TO THESE BATCHES WERE FOUND. MAINTENANCE REVIEW: ACCORDING MAINTENANCE RECORDS NUMBER # (B)(4), ONE SHIELD CRASHER DEVICE FAILURE WAS DETECTED. MAINTENANCE WAS REQUESTED AND THE PROCESS CORRECTED. THE NEEDLE HUB DAMAGED, ACCORDING PICTURE SENT BY THE CUSTOMER, OCCURRED DUE TO ONE SHIELD CRASHER DEVICE FAILURE ACCORDING MAINTENANCE RECORDS. THIS IS AN ANOMALOUS FAILURE. THE DEFECT IDENTIFIED BY THIS COMPLAINT WILL BE MONITORED. CAPA IS NOT REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK HYPODERMIC SYRINGE WITH NEEDLE HUB WAS BROKEN BEFORE USE.

    Additional Manufacturer Narrative · 1

    (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 BD¿ PLASTIPAK HYPODERMIC SYRINGE WITH NEEDLE HUB WAS BROKEN BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023698 BD¿ PLASTIPAK HYPODERMIC SYRINGE WITH NEEDLE SYRINGE WITH NEEDLE FMI BECTON DICKINSON IND. CIRURGICAS LTDA 7173878

    Patients

    Seq Age Sex Outcome Treatment
    1 Other