BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-SLIP SYRINGE WITH THE BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 16219774 · Received January 20, 2023

    Report

    Report Number
    8041187-2023-00006
    Event Type
    Malfunction
    Date Received
    January 20, 2023
    Date of Event
    January 3, 2023
    Report Date
    March 30, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    UDI-DI
    00382903021048
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 26-JAN-2023 . H6: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE 5 SAMPLES FOR LOT 2171881 SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF PLUNGER MOVEMENT DIFFICULT WAS NOT CONFIRMED UPON INSPECTION AND TESTING OF THE SAMPLES. ANALYSIS OF THE SAMPLE SHOWED THAT THEY WERE ALL WITHIN PROPER SPECIFICATIONS. THE SAMPLES WERE FUNCTIONALLY TESTED, AND THEY ALL PASSED. BD CANNOT DETERMINE A ROOT CAUSE SINCE THE DEFECT REPORTED WAS NOT CONFIRMED. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD LUER-SLIP SYRINGE WITH THE BD PRECISIONGLIDE¿ NEEDLE THE PLUNGER WAS DIFFICULT TO MOVE. THIS OCCURRED 5 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLUNGER IS HARD TO PUSH - 5EA.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD LUER-SLIP SYRINGE WITH THE BD PRECISIONGLIDE¿ NEEDLE THE PLUNGER WAS DIFFICULT TO MOVE. THIS OCCURRED 5 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLUNGER IS HARD TO PUSH - 5EA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895630 BD LUER-SLIP SYRINGE WITH THE BD PRECISIONGLIDE¿ NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) 2171881 00382903021048

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown