BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 60ML SYRINGE LUER-LOK TIP

    MDR report key: 9594086 · Received January 15, 2020

    Report

    Report Number
    1911916-2020-00013
    Event Type
    Malfunction
    Date Received
    January 15, 2020
    Date of Event
    December 27, 2019
    Report Date
    January 24, 2020
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWO (2) SAMPLES WERE RECEIVED FOR INVESTIGATION. ONE (1) SAMPLE WAS RECEIVED IN AN OPENED BLISTER PACK AND THE OTHER SAMPLE WAS RECEIVED IN AN UNOPENED BLISTER PACK. BOTH THE RETURNED SAMPLES WERE VISUALLY EXAMINED USING UNAIDED VISION AND BOTH WERE FOUND TO BE MISSING ALMOST ALL THE PRINT FROM THE SYRINGE BARRELS. A MACHINE MALFUNCTION DURING THE PRINTING PROCESS CAN CAUSE MISSING PRINT. THIS CAN BE DUE TO EITHER A LACK OF PRESSURE BETWEEN THE PRINT PAD AND THE SYRINGE OR A MISALIGNMENT OF THE LOAD FINGERS OR CHAINS THAT PRESS THE SYRINGE INTO THE PRINTING PAD. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SCALE MARKING ISSUES WERE FOUND BEFORE USE WITH A BD 60ML SYRINGE LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE GRADUATION MARKINGS WERE MISSING FROM TWO SYRINGES. I HAVE IN MY POSSESSION TWO 50-ML BD LUER-LOK SYRINGES (REF# (B)(4) THAT ARE MISSING THE CALIBRATIONS ON THE BARREL COMPLETELY. THE LOT NUMBER IS 9240211. 2 OCCURRENCES WERE REPORTED.

    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 SCALE MARKING ISSUES WERE FOUND BEFORE USE WITH A BD 60ML SYRINGE LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE GRADUATION MARKINGS WERE MISSING FROM TWO SYRINGES. I HAVE IN MY POSSESSION TWO 50-ML BD LUER-LOK SYRINGES (REF#309563) THAT ARE MISSING THE CALIBRATIONS ON THE BARREL COMPLETELY. THE LOT NUMBER IS 9240211." 2 OCCURRENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57274 BD 60ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON AND COMPANY 309653 9240211 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 Other