BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE

    MDR report key: 18522489 · Received January 16, 2024

    Report

    Report Number
    1213809-2024-00005
    Event Type
    Malfunction
    Date Received
    January 16, 2024
    Date of Event
    December 15, 2023
    Report Date
    January 8, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903031344
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    IT WAS REPORTED THAT THE BD SYRINGE BARREL/FLANGE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ORDERED A BD SYRINGE THOUGH MEDLINE THAT WE BELIEVE FALLS UNDER THIS ISSUE. WE HAVE A VERGE REPORTS ON THE DEVICE BREAKING AND SPRAYING BLOOD DURING A DRAW. I HAVE INCLUDED THE BD ALSO IF THEY WOULD DO THE QA VS. MEDLINE." ADDITIONAL INFORMATION RECEIVED ON 01/08/2024: 1. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? NO. 2. WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? YES. 3. ANY SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION? NO. 4. HOW WAS THE PATIENT OUTCOME? ARE THERE ANY CLINICAL SIGNS, HEALTH CONSEQUENCES OR IMPACT? NO. 5. HOW WAS TREATMENT COMPLETED FOR CUSTOMER? GRABBED ANOTHER SYRINGE. 6. PATIENT STATUS?N/A. 7. ANY PICTURE OF THIS COMPLAINT NO. 8.PLEASE EXPLAIN ELABORATE ISSUE? WHEN USING A 10 ML SLIP TIP BD SYRINGE TO DRAW A BLOOD SAMPLE FROM IV START, THERE WAS A HOLE IN THE SYRINGE CHAMBER STRAIGHT FROM PACKAGE. THIS WAS NOT NOTICED UNTIL BLOOD STARTING COMING FROM THE HOLE. 9. DATE OF EVENT? 12/15.2023. 10.PHYSICAL AVAILABLE/NOT AVAILABLE? NO. 12. CUSTOMER ADDRESS? (B)(6). 13.THIS MATERIAL NUMBER IS CORRECT OR NOT? CORRECT. 14.PLEASE PROVIDE CORRECT BATCH NUMBER? C-198 8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916730 BD SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 00382903031344

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown