BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 ML BD LUER-LOK SYRINGE WITH BD PRECISIONGLIDE NEEDLE

    MDR report key: 9448973 · Received December 10, 2019

    Report

    Report Number
    1213809-2019-01252
    Event Type
    Malfunction
    Date Received
    December 10, 2019
    Date of Event
    November 21, 2019
    Report Date
    December 31, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096443
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    MATERIAL NO. 309644 BATCH NO. 7210934. IT WAS REPORTED THAT AFTER USE OF THE 10 ML BD LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE AN EXPIRED NEEDLE WAS USED FOR TWO WEEKS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A CONTACT FOR PERITONEAL DIALYSIS PATIENT CONTACTED CUSTOMER SERVICE TO REPORT THAT THE PATIENT WAS UNAWARE AND WAS USING THE EXPIRED NEEDLE FOR THE LAST 2 WEEKS. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED."

    Additional Manufacturer Narrative · 1

    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

    MATERIAL NO. 309644 BATCH NO. 7210934. IT WAS REPORTED THAT AFTER USE OF THE 10 ML BD LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE AN EXPIRED NEEDLE WAS USED FOR TWO WEEKS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A CONTACT FOR PERITONEAL DIALYSIS PATIENT CONTACTED CUSTOMER SERVICE TO REPORT THAT THE PATIENT WAS UNAWARE AND WAS USING THE EXPIRED NEEDLE FOR THE LAST 2 WEEKS. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243360 10 ML BD LUER-LOK SYRINGE WITH BD PRECISIONGLIDE NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309644 7210934 30382903096443

    Patients

    Seq Age Sex Outcome Treatment
    1 Other