BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP

    MDR report key: 8404793 · Received March 8, 2019

    Report

    Report Number
    1213809-2019-00314
    Event Type
    Malfunction
    Date Received
    March 8, 2019
    Date of Event
    February 20, 2019
    Report Date
    April 23, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO AND ONE 3ML SYRINGE IN AN OPENED BLISTER PACK FROM BATCH #8213794 (P/N 309657). WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THE SYRINGE HAD A SKEWED SCALE WITH NO MARKINGS BELOW THE 1.5ML GRAD LINE. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. CORRECTIVE AND PREVENTATIVE ACTION WAS OPENED TO INVESTIGATE. CAPA#753644.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCALE MARKINGS WERE MISSING FROM THE BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP. AS REPORTED BY THE CUSTOMER, "LOT NUMBER 8213794 FOR 309657 IS ALSO MISSING SCALE MARKINGS. CUSTOMER CAME ACROSS THIS ITEM WHEN CHECKING ITEMS 309657 AND 309606 FROM BD RECALL, EVENT-2019-01979-BECTON DICKINSON. FOLLOWING ARE THE LOT NUMBERS FROM RECALL. MATERIAL 309657 LOT 830357 AND MATERIAL 309606 LOT 8307694. LOT 8213794 MATERIAL 309657 WAS NOT PART OF RECALL, BUT CUSTOMER REPORTED ITEM IS MISSING SCALE MARKINGS."

    Additional Manufacturer Narrative · 1

    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 THE SCALE MARKINGS WERE MISSING FROM THE BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP. AS REPORTED BY THE CUSTOMER, "LOT NUMBER 8213794 FOR 309657 IS ALSO MISSING SCALE MARKINGS. CUSTOMER CAME ACROSS THIS ITEM WHEN CHECKING ITEMS 309657 AND 309606 FROM BD RECALL, EVENT-2019-01979-BECTON DICKINSON. FOLLOWING ARE THE LOT NUMBERS FROM RECALL. MATERIAL 309657 LOT 830357 AND MATERIAL 309606 LOT 8307694. LOT 8213794 MATERIAL 309657 WAS NOT PART OF RECALL, BUT CUSTOMER REPORTED ITEM IS MISSING SCALE MARKINGS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195906 BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8213794 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other