BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML LL W/O DN

    MDR report key: 8995089 · Received September 11, 2019

    Report

    Report Number
    1213809-2019-00922
    Event Type
    Malfunction
    Date Received
    September 11, 2019
    Date of Event
    August 5, 2019
    Report Date
    October 24, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, SO WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. 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. NO CORRECTIVE ACTIONS RECOMMENDED SINCE SAMPLES/PHOTOS WERE NOT RECEIVED TO CONFIRM THE PRODUCT DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 1ML LL W/O DN EXPERIENCED TIP/LUER OF SYRINGE CRACKED/DEFORMED/DAMAGED/BENT. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309628 BATCH NO: 9112924. EVENT DESCRIPTION -DEFECTIVE BD 1 ML LUER-LOK TIP SYRINGE. SYRINGE OPENING CONTAINING THE TIP IS FLATTENED AND NOT PERFECTLY ROUND. THUS, SYRINGE CANNOT BE ATTACHED TO OTHER LUER-LOK DEVICES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6).  FDA NOTIFIED: THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON (DATE) VIA MEDWATCH # MW5088858. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 1 ML LL W/O DN EXPERIENCED TIP/LUER OF SYRINGE CRACKED/DEFORMED/DAMAGED/BENT. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309628, BATCH NO: 9112924. EVENT DESCRIPTION -DEFECTIVE BD 1 ML LUER-LOK TIP SYRINGE. SYRINGE OPENING CONTAINING THE TIP IS FLATTENED AND NOT PERFECTLY ROUND. THUS, SYRINGE CANNOT BE ATTACHED TO OTHER LUER-LOK DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794422 SYRINGE 1ML LL W/O DN PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9112924 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other