BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SLIP-TIP SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 13160045 · Received January 4, 2022

    Report

    Report Number
    1213809-2021-00835
    Event Type
    Malfunction
    Date Received
    January 4, 2022
    Date of Event
    December 3, 2021
    Report Date
    January 6, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095972
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY . TWO PHOTOS WERE RECEIVED AND EVALUATED. ONE PHOTO DISPLAYED THE GRAPHIC SIDE OF A BLISTER PACKAGE (P/N 309597) FROM BATCH #0150719. THE SECOND PHOTO DISPLAYED A 1ML SYRINGE WITH NEEDLE IN ITS BLISTER PACKAGE WITH NEEDLE ATTACHED. AN ARROW POINTING TO THE NEEDLE/TIP CONNECTION WAS PRESENT. THE CONNECTION DID NOT APPEAR TO BE IRREGULAR FROM THE PHOTO AND NO NON-CONFORMITIES WERE OBSERVED. UNUSED PHYSICAL SAMPLES ARE NEEDED TO PERFORM A MORE IN-DEPTH EVALUATION. SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED AND CORRECTIVE ACTIONS ARE NOT NECESSARY. 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 BD¿ SLIP-TIP SYRINGES WITH ATTACHED NEEDLE PLUNGERS WERE DIFFICULT TO PUSH DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SPOKE WITH PATIENT'S DAUGHTER COMPLAINTS THAT PLUNGER ON INJECTION SYRINGES ARE SOMETIMES HARD TO PUSH, STATES IT OCCURS IN ABOUT FIVE SYRINGES OUT OF A MONTH SUPPLY."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 BD¿ SLIP-TIP SYRINGES WITH ATTACHED NEEDLE PLUNGERS WERE DIFFICULT TO PUSH DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SPOKE WITH PATIENT'S DAUGHTER COMPLAINTS THAT PLUNGER ON INJECTION SYRINGES ARE SOMETIMES HARD TO PUSH, STATES IT OCCURS IN ABOUT FIVE SYRINGES OUT OF A MONTH SUPPLY."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 BD¿ SLIP-TIP SYRINGES WITH ATTACHED NEEDLE PLUNGERS WERE DIFFICULT TO PUSH DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SPOKE WITH PATIENT'S DAUGHTER COMPLAINTS THAT PLUNGER ON INJECTION SYRINGES ARE SOMETIMES HARD TO PUSH, STATES IT OCCURS IN ABOUT FIVE SYRINGES OUT OF A MONTH SUPPLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479506 BD¿ SLIP-TIP SYRINGE WITH ATTACHED NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309597 0150719 30382903095972

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown