BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20279268 · Received September 23, 2024

    Report

    Report Number
    1213809-2024-00647
    Event Type
    Malfunction
    Date Received
    September 23, 2024
    Date of Event
    September 3, 2024
    Report Date
    November 7, 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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) - SUPPLEMENTAL MDR - NEEDLE PULLED OUT OF HUB. SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. 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.

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E.1. ADDRESS WAS NOT LOCATED AND IL WAS USED. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    MATERIAL # 309623 BATCH # 0073307. IT WAS REPORTED THAT THE BD SYRINGE 1ML S/T W/NDL 27X1/2 RB NEEDLE PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT NEEDLE CAME OUT DURING INJECTION. RCC RECEIVED A COMPLAINT VIA EMAIL. ITEM(S): 309623 LOT(S): 0073307 DATE INCIDENT OCCURRED: ONGOING WAS THE PATIENT IMPACTED? NEEDLE CAME OUT DURING INJECTION IF YES, DESCRIBE: PURCHASED FROM PHARMACY IS A SAMPLE AVAILABLE?: NO CUSTOMER REQUEST?:

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488720 BD SYRINGE 1ML S/T W/NDL 27X1/2 RB PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 0073307 30382903096238

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown