BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 1ML S/T W/NDL 27X1/2 RB

    MDR report key: 19982372 · Received August 14, 2024

    Report

    Report Number
    1213809-2024-00541
    Event Type
    Malfunction
    Date Received
    August 14, 2024
    Date of Event
    July 14, 2024
    Report Date
    October 4, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096238
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION. THREE SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED WITH 30X MAGNIFICATION, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. BASED ON THE INVESTIGATION WITH SAMPLE ANALYSIS THE SYMPTOM REPORTED COULD NOT BE CONFIRMED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 3143581. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    MATERIAL# 309623 BATCH# 3143581 IT WAS REPORTED THAT THE BD SYRINGE 1ML S/T W/NDL 27X1/2 RB HAD A SYRINGE NEEDLE CONNECTIVITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED ITEM(S): 309623 LOT(S): 3143581. DATE INCIDENT OCCURRED: WAS THE PATIENT IMPACTED? IF YES, DESCRIBE: YES. THE NEEDLE IS COMING OFF THE SYRINGE UPON INJECTION. CUSTOMER USES FOR ALLERGY MEDS. SHE HAS TO MIX TWO MEDICATIONS. WHEN THE NEEDLE COMES, SHE DOESN'T KNOW HOW MUCH MEDICATION SHE IS ACTUALLY RECEIVING BECAUSE SO MUCH DRAINS OUT ADDITIONAL INFORMATION PROVIDED: THE DATE OF THE EVENTS WERE JULY 14 & JULY 21. I HAVE SAVED THE SYRINGES. YOU CAN SEND THE RETURN LABEL TO MY HOME ADDRESS: (B)(6).

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535068 BD SYRINGE 1ML S/T W/NDL 27X1/2 RB PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3143581 30382903096238

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown