BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL BNS

    MDR report key: 18461464 · Received January 7, 2024

    Report

    Report Number
    1213809-2023-01517
    Event Type
    Malfunction
    Date Received
    January 7, 2024
    Date of Event
    December 11, 2023
    Report Date
    May 9, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    50382903010733
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.

    Additional Manufacturer Narrative · 0

    TWO PHOTOS OF A 3ML LUER-LOK SYRINGE WERE RECEIVED AND EVALUATED. BOTH PHOTOS WITH ONE A CLOSE-UP SHOWS A LOOSE SYRINGE FILLED WITH AN UNKNOWN FLUID WITH AN UNKNOWN BROWN PARTICULATE LARGER THAN LEVEL 4 IN THE NON-FLUID PATH. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER NON-FLUID PATH DEFECT IS ASSOCIATED WITH THE BULK HANDLING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2297482 SHOWING 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

    IT WAS REPORTED THAT THE BD SYRINGE 3ML LL BNS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN DRAWING THIS SYRINGE, I NOTICED WHAT APPEARS TO BE PIECE OF CARDBOARD/DIRT." VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. COMPLAINT NUMBER (B)(4). PRODUCT CODE BX301073. LOT NUMBER 2297482, 3143639. PRODUCT DESCRIPTION UNIVERSAL ANES.TRAY MRX.. COMPLAINT DESCRIPTION WHEN DRAWING THIS SYRINGE, I NOTICED WHAT APPEARS TO BE PIECE OF CARDBOARD/DIRT. SAMPLE AVAILABILITY NO. PATIENT INJURY NO. SHOULD YOU HAVE ANY MORE QUESTIONS PLEASE LET ME KNOW.

    Description of Event or Problem · 0

    MATERIAL#: 301073, LOT#: 2297482,3143639. IT WAS REPORTED BY THE CUSTOMER REPORTED THAT WHEN DRAWING THIS SYRINGE, I NOTICED WHAT APPEARS TO BE PIECE OF CARDBOARD/DIRT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. COMPLAINT NUMBER (B)(4). PRODUCT CODE BX301073. LOT NUMBER 2297482, 3143639. PRODUCT DESCRIPTION UNIVERSAL ANES TRAY MRX. COMPLAINT DESCRIPTION WHEN DRAWING THIS SYRINGE, I NOTICED WHAT APPEARS TO BE PIECE OF CARDBOARD/DIRT. SAMPLE AVAILABILITY: NO. PATIENT INJURY: NO. SHOULD YOU HAVE ANY MORE QUESTIONS PLEASE LET ME KNOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568359 BD SYRINGE 3ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3143639 50382903010733

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown