BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 5ML SYRINGE LUER-LOK ¿ TIP

    MDR report key: 15165256 · Received August 4, 2022

    Report

    Report Number
    9610847-2022-00281
    Event Type
    Malfunction
    Date Received
    August 4, 2022
    Date of Event
    July 5, 2022
    Report Date
    August 24, 2022
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    00382903097036
    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

    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.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE 10 SAMPLES AND ONE PHOTOGRAPH SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF PLUNGER ROD BROKEN / DAMAGED WAS CONFIRMED UPON INSPECTION OF THE SAMPLES. FIVE LOOSE SAMPLES FROM BATCH 2090479 HAVE BROKEN PLUNGER RODS ON FOUR OF THE SYRINGES AND ONE OF THE SYRINGES HAS CRACKED GATE BLOCK WITHIN ACCEPTABLE LIMITS FROM THE ROOF OF THE BARREL UP TO THE BARREL TIP. THE IMAGE SHOWS 2 PLUNGER RODS INSIDE THE BARRELS WITH BOTH PLUNGER RODS CRACKED IN TWO PLACES FROM AN UNKNOWN BATCH #. BD DETERMINED THAT THE POTENTIAL ROOT CAUSE FOR THE CRACKED PLUNGER ROD DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. SEE H10.

    Description of Event or Problem · 0

    THIS MDR IS THE FIRST OF 3 RELATED MDRS AND ADDRESSES THE LOT # 2090479 EVENT. IT WAS REPORTED THAT 19 BD 5ML SYRINGE LUER-LOK ¿ TIP HAD CRACKED PLUNGER RODS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CUSTOMER REPORTED SYRINGES WITH CRACKED PLUNGER RODS.

    Description of Event or Problem · 0

    THIS MDR IS THE FIRST OF 3 RELATED MDRS AND ADDRESSES THE LOT # 2090479 EVENT. IT WAS REPORTED THAT 19 BD 5ML SYRINGE LUER-LOK ¿ TIP HAD CRACKED PLUNGER RODS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CUSTOMER REPORTED SYRINGES WITH CRACKED PLUNGER RODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2111407 BD 5ML SYRINGE LUER-LOK ¿ TIP PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 2090479 00382903097036

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown