BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE WITH NEEDLE

    MDR report key: 7342178 · Received March 15, 2018

    Report

    Report Number
    2243072-2018-00133
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    February 21, 2018
    Report Date
    May 17, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS 1711302. BLACK COLOR FOREIGN MATTER WAS OBSERVED OUTSIDE OF THE SYRINGE OF THE COMPLAINT SAMPLE. FOREIGN MATTER ANALYSIS: SBDM ANALYSIS THE FM USING INFRARED SPECTROMETRY. BASED ON THE RESULTS, THE MATERIAL OF FM WAS POLYPROPYLENE, THE SAME RAW MATERIAL OF BARREL COMPONENT OF THE SYRINGE. HOUSE SAMPLE INSPECTION: SBDM INSPECTED 25 PCS OF THE HOUSE SAMPLE FOR LOT 1711302. NO FOREIGN MATTER WAS OBSERVED ON THE HOUSE SAMPLES. DEVICE HISTORY RECORD REVIEW: SBDM REVIEWED THE MANUFACTURING RECORDS FOR LOT 171132. NO ABNORMALITY WAS OBSERVED. SBDM COMPLAINT RECORD REVIEW: SBDM REVIEWED CUSTOMER COMPLAINT RECORD FOR LOT 1711302, THERE IS NO REPEATED COMPLAINTS OF SAME ISSUE FROM OTHER CUSTOMERS. THE LIKELY CAUSE IS THE FOREIGN MATTER ON THE COMPLAINT SAMPLE IS COMPRESSED BURR OF A PLUNGER, THE BURR OCCURRED DURING INJECTION MOLDING PROCESS. DUE TO STATIC ELECTRICITY, THE BURR WAS ATTACHED ON THE BARREL OF THE COMPLAINT SAMPLE. SBDM HAD QUALITY TRAINING ON THIS CUSTOMER COMPLAINT FOR SYRINGE ASSEMBLY LINE WORKERS AND PLUNGER MOLDING LINE WORKERS. SBDM ENHANCE MONITORING OF SYRINGE MANUFACTURING PROCESS AND ITS HANDLING PROCESS TO PREVENT SIMILAR CASE OF QUALITY ISSUE. SBDM ARE CHECKING AND RECONFIRMING OF MOLDING WORK CONDITION AND IMPLEMENTING OF PREVENTIVE MAINTENANCE FOR SYRINGE MOLD. SBDM IMPLEMENT ENHANCED SYRINGE ASSEMBLY MACHINE CLEANING 3 TIMES PER DAY (BEFORE WORK, BEFORE LUNCH TIME AND AFTER FINISH WORK). BASED ON INVESTIGATION, INFRARED SPECTROMETRY ANALYSIS OF THE FM CONCLUDED THE MATERIAL TO BE POLYPROPYLENE, THE SAME RAW MATERIAL OF BARREL COMPONENT OF THE SYRINGE. THE LIKELY CAUSE IS THE FM ON THE COMPLAINT SAMPLE IS COMPRESSED BURR OF A PLUNGER, THE BURR OCCURRED DURING INJECTION MOLDING PROCESS. DUE TO STATIC ELECTRICITY, THE BURR WAS ATTACHED ON THE BARREL OF THE COMPLAINT SAMPLE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 FOREIGN MATTER WAS FOUND INSIDE A BD¿ SYRINGE WITH NEEDLE BETWEEN THE BARREL AND THE STOPPER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185336 BD¿ SYRINGE WITH NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON 1711302

    Patients

    Seq Age Sex Outcome Treatment
    1 Other