BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 50ML SYRINGE

    MDR report key: 8395665 · Received March 6, 2019

    Report

    Report Number
    2243072-2019-00419
    Event Type
    Malfunction
    Date Received
    March 6, 2019
    Date of Event
    February 18, 2019
    Report Date
    April 23, 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: 1 SAMPLE WAS RETURNED TO SBDM. FROM INVESTIGATIONS, THE LIKELY CAUSE IS DUE TO SYRINGE ASSEMBLY PROCESS, SBDM ASSUME THAT THE FM IN THE BARREL WAS OCCURRED WHILE THE PLUNGER WAS FEEDING TO SYRINGE ASSEMBLY MACHINE. THE PLUNGER WAS NOT MOVING TO INDEX OF SYRINGE ASSEMBLY MACHINE PROPERLY, THUS CAUSING THE PLUNGER TO BREAK. THE BROKEN PIECE MOST LIKELY WAS PUSHED BY AIR INTO THE BARREL, WHEN THE ASSEMBLY MACHINE WAS STARTING OR STOPPING. HOUSE SAMPLE INSPECTION: SBDM INSPECTED 30 PCS EACH FOR 3 LOTS (LOT 1810013, 1810224 AND 1812062, NO ABNORMALITY WAS OBSERVED. DEVICE HISTORY R REVIEW: SBDM REVIEWED THE MANUFACTURING RECORD FOR LOT 1810224, NO ABNORMALITY WAS OBSERVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ 50ML SYRINGE HAD FOREIGN MATTER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD¿ 50ML SYRINGE HAD FOREIGN MATTER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186961 BD 50ML SYRINGE SYRINGE FMF BECTON DICKINSON 1810224

    Patients

    Seq Age Sex Outcome Treatment
    1 Other