BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ HYPODERMIC SYRINGE WITH NEEDLE

    MDR report key: 7187063 · Received January 12, 2018

    Report

    Report Number
    3003916417-2017-00122
    Event Type
    Malfunction
    Date Received
    January 12, 2018
    Date of Event
    December 20, 2017
    Report Date
    January 15, 2018
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS SENT BY THE CUSTOMER AND WAS VERIFIED AND IT WAS POSSIBLE TO OBSERVE FOREIGN MATTER  LUBRICANT RESIDUE. DHR REVIEW: IT WAS VERIFIED THE RECORD OF THE BATCHS AND THE MANUFACTURING DATE FOR THE BATCH 7193623: AUGUST 1ST TO 2ND, 2017 AND BATCH 7173517 JULY 24TH AND 25TH, 2017. THE PROCESS INSPECTIONS WERE PERFORMED AND NO RECORDS OF THIS DEFECT WERE FOUND. CONCLUSION: CONFIRMED: BD WAS ABLE TO CONFIRM THE CUSTOMERS INDICATED FAILURE. 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. THE POTENTIAL CAUSE FOR THE PROBLEM IS FAILURE AT SYRINGE LUBRICANT SYSTEM IN THE ASSEMBLY MACHINE CAUSING THE DEPOSITION OF CRYSTALLIZED SILICONE RESIDUE INTO THE SYRINGE. THE OPERATORS WILL BE NOTIFIED FROM THIS COMPLAINT TO VERIFY THE MANUAL LUBRIFICANT SYSTEM OPERATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BEFORE USE OF THE BD" SYRINGE 10ML SYRINGE HAS DIRT IN THE INITIAL PART. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31518 BD PLASTIPAK¿ HYPODERMIC SYRINGE WITH NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON IND. CIRURGICAS LTDA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other