BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 50CC LL TIP CONVENIENCE PAK

    MDR report key: 18088485 · Received November 7, 2023

    Report

    Report Number
    9610847-2023-00299
    Event Type
    Malfunction
    Date Received
    November 7, 2023
    Date of Event
    September 5, 2023
    Report Date
    February 16, 2024
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903096801
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED. 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 OF THE AFFECTED DEVICE. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. WE REGRET ANY INCONVENIENCES THIS INCIDENT MAY HAVE CAUSED YOU AND YOUR FACILITY. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 50CC LL TIP CONVENIENCE PAK LEAKED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; IT WAS REPORTED BY CUSTOMER THAT FDA IS ON-SITE AT SCA¿S WINDSOR FACILITY AND HAS BEEN LOOKING INTO FOREIGN MATERIAL (CARDBOARD FOREIGN MATERIAL HAIR) IN SYRINGE TRAYS. IN LIEU OF ISSUING OUT SEPARATE COMPLAINTS FOR THE DEFECTS WE HAVE SEEN IN THE PAST YEAR SCA DETERMINED THAT ONE SUPPLIER COMPLAINT WOULD BE INITIATED. VERBATIM: GOOD MORNING AS YOU MAY BE AWARE THE FDA IS ON-SITE AT SCA¿S WINDSOR FACILITY AND HAS BEEN LOOKING INTO FOREIGN MATERIAL (CARDBOARD FOREIGN MATERIAL HAIR) IN SYRINGE TRAYS. IN LIEU OF ISSUING OUT SEPARATE COMPLAINTS FOR THE DEFECTS WE HAVE SEEN IN THE PAST YEAR SCA DETERMINED THAT ONE SUPPLIER COMPLAINT WOULD BE INITIATED. SCA PART NUMBER: R15028, BD PART NUMBER: 309680, DESCRIPTION: SYRINGE (STERILE), 50 ML LL, BD TRAY *309680* (20/TRAY; 6 TRAY/CS), # OF TRAYS WITH DEFECTS: (B)(4). # OF FINISHED UNITS REJECTED DUE TO DEFECTS: (B)(4).

    Description of Event or Problem · 0

    NO NEW INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1536987 BD SYRINGE 50CC LL TIP CONVENIENCE PAK SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 2202942 30382903096801

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown