BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE INTEGRA 3ML W/NDL 22X1-1/2 RB

    MDR report key: 20571568 · Received October 30, 2024

    Report

    Report Number
    1213809-2024-00775
    Event Type
    Malfunction
    Date Received
    October 30, 2024
    Date of Event
    October 4, 2024
    Report Date
    December 5, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052722
    PMA / PMN Number
    K011103
    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.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.

    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.

    Description of Event or Problem · 0

    MATERIAL#: 305272, BATCH#: 1110062. IT WAS REPORTED THAT THE BD SYRINGE INTEGRA 3ML W/NDL 22X1-1/2 RB NEEDLE PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. PRODUCT COMPLAINT: REF (B)(4) AND LOT 1110062 FOR THE INJECTION. ISSUE: DR SUSPECTED NEEDLE SEPARATED FROM DEVICE, SUSPECTS NEEDLE MIGHT HAVE BE LODGED IN PT. MED INFO CONFIRMED THAT THE DEVICE DOES RETRACT. ADMINISTERED TESTOSTERONE. PT HARM: UNKNOWN.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1963031 BD SYRINGE INTEGRA 3ML W/NDL 22X1-1/2 RB SYRINGE, ANTISTICK MEG BECTON DICKINSON MEDICAL SYSTEMS 1110062 30382903052722

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown