BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL EURO 125 S/C

    MDR report key: 19008864 · Received March 29, 2024

    Report

    Report Number
    1213809-2024-00189
    Event Type
    Malfunction
    Date Received
    March 29, 2024
    Date of Event
    April 20, 2022
    Report Date
    August 13, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    50382903096485
    PMA / PMN Number
    K941562
    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

    DEVICE EVALUATION: 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. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE.

    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

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 5ML LL EURO 125 S/C HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OILY RESIDUE FOUND ON SYRINGES" RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. MEDLINE COMPLAINT (B)(4) DEFECT DESCRIPTION: OILY RESIDUE FOUND ON SYRINGES MEDLINE PART #: 26001 PRODUCT DESCRIPTION: DNQ BFC SYR 3ML L/L VENDOR PART #: 301073 LOT #: UNKNOWN DATE REPORTED: 04/20/2022 SAMPLE RECEIVED: NO RESPONSE NEEDED: SUMMARY OF FINDINGS AND CORRECTIVE ACTION COMPLAINT REPORTED TO FDA AS MDR-30 DAY. REFERENCE NO. (B)(4) ADDITIONAL INFORMATION PROVIDED: 1.SAMPLE SHIPPING DETAILS? ANY PHOTOS AND VIDEOS NO ADDITIONAL SHIPPING DETAILS 2.ANY PICTURE OF THIS COMPLAINT? 3.HOW WAS TREATMENT COMPLETED FOR CUSTOMER? UNKNOWN 4.CUSTOMER ADDRESS? (B)(6) 5. DATE OF EVENT? 4/20/2022 6.PLEASE PROVIDE BATCH NUMBER? 301073 ¿ UNKNOWN LOT, 09648 ¿ LOT 1201884.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2586010 BD SYRINGE 5ML LL EURO 125 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 1201884 50382903096485

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown