BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 50ML SYRINGE

    MDR report key: 8344578 · Received February 15, 2019

    Report

    Report Number
    2243072-2019-00247
    Event Type
    Malfunction
    Date Received
    February 15, 2019
    Date of Event
    January 28, 2019
    Report Date
    February 22, 2019
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS 1810013. ERASE TEST FOR COMPLAINT SAMPLE: SBDM SOAK THE COMPLAINT SAMPLE IN BOTH FRESH MILK AND RECEIVED MILK TOGETHER WITH COMPLAINT SAMPLE FOR 24 HOURS, THE SCALE WAS FOUND TO BE INTACT AND NOT ERASED. ERASE TEST FOR HOUSE SAMPLE: SBDM SOAK 10 PCS HOUSE SAMPLE FROM LOT 1810013 IN THE RECEIVED MILK AND FRESH MILK FOR 2 HOURS PER SAMPLE, THE SCALE WAS FOUND TO BE INTACT AND NOT ERASED. DEVICE HISTORY RECORD REVIEW: SBDM REVIEWED THE MANUFACTURING RECORD FOR LOT 1810013, NO ABNORMALITY WAS OBSERVED. CUSTOMER COMPLAINT REVIEW: SBDM REVIEWED INTERNAL CUSTOMER COMPLAINT RECORD, THERE IS NO SAME ISSUE FOR SAME PRODUCT FROM OTHER CUSTOMER. CORRECTIVE ACTIONS: SBDM CONDUCT QUALITY TRAINING ON THIS CUSTOMER COMPLAINT FOR SYRINGE ASSEMBLY LINE WORKERS. SBDM IMPLEMENT ENHANCED SYRINGE ASSEMBLY MACHINE CLEANING 3 TIMES EVERY WORKING DAY (BEFORE STARTING WORK, BEFORE LUNCH TIME AND AFTER FINISH WORK) SBDM WILL CONTINUE TO MONITOR SYRINGE ASSEMBLY PROCESS. SBDM ARE IMPLEMENTING 100% VISUAL INSPECTION ON SYRINGE PACKAGING PROCESS AND HAD RETRAINED ON INSPECTION METHOD FOR PACKAGING INSPECTOR DUE TO THIS COMPLAINT CASE EFFECTIVE. CONCLUSION: 1 SAMPLE WAS RETURNED TO SBDM. FROM INVESTIGATION, SBDM VERIFY THAT THE SCALE COULD NOT BE ERASED BY MILK ALONE. IT IS ASSUMED THE MILK WAS NOT THE DIRECT CAUSE. THE LIKELY CAUSE IS DUE TO EXTERNAL FACTOR SUCH AS DAMAGE BY LATEX GLOVE, DAMAGE BY NAIL OR TOUCH WITH ALCOHOL CLEANING GAUZE FOR DISINFECTION MAY CONTRIBUTE TO THE DEFECT EXPERIENCE BY CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD¿ 50ML SYRINGE THE SCALE MARKING WAS ERASED.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD¿ 50ML SYRINGE THE SCALE MARKING WAS ERASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135528 BD 50ML SYRINGE SYRINGE FMF BECTON DICKINSON 1810013

    Patients

    Seq Age Sex Outcome Treatment
    1 Other