BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM DIABETES 3ML LL SYR WITH CO-PACKED NEEDLE 26GX3/8''

    MDR report key: 20990090 · Received December 20, 2024

    Report

    Report Number
    1035907-2024-00027
    Event Type
    Malfunction
    Date Received
    December 20, 2024
    Date of Event
    November 10, 2024
    Report Date
    November 25, 2024
    Manufacturer
    EXELINT INTERNATIONAL, CO.
    Product Code
    FMF
    PMA / PMN Number
    K861153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE INCOMING INSPECTION HAS BEEN PERFORMED ON PRODUCT # 1001215, LOT 220611 IN ACCORDANCE WITH SOP-11, INCOMING INSPECTION PROCEDURE. THE LOT PASSED THE INSPECTION WITH NO NON-CONFORMITIES REPORTED. THE CMO HAS CONDUCTED AN INSPECTION AND TESTING ON RETAIN SAMPLES FOR PRODUCT # 1001215, LOT # 220611 WITH THE FOLLOWING RESULTS: PRODUCTION PROCESS REVIEW: THE BATCH PRODUCTION PROCESS AND PRODUCT INSPECTION REPORT WERE REVIEWED. THE RECORDS WERE FOUND TO COMPLY WITH THE REQUIRED STANDARDS. VISUAL INSPECTION: ALL 89 REMAINING RETENTION SAMPLES WERE VISUALLY INSPECTED INDIVIDUALLY. ALL TESTED SAMPLES PASSED THE INSPECTION, WITH NO VISIBLE LIQUID FOUND IN THE PRODUCT CAVITY. EFFORTS WERE MADE TO OBTAIN THE PRODUCT IN QUESTION AND AND DOCUMENTARY EVIDENCE FROM THE COMPLAINANT. THE COMPLAINANT FAILED TO PROVIDE THE PRODUCT IN QUESTION FOR EXAMINATION. IN SUMMARY, ALL RETAINED SAMPLES INSPECTED WERE FOUND TO BE QUALIFIED FOR PRODUCT RELEASE. NO VISIBLE LIQUID OR CONTAMINATION WAS FOUND. ALL DOCUMENTS ( THE BATCH PRODUCTION PROCESS, PRODUCT INSPECTION REPORT, AND THE INCOMING INSPECTION) WERE FOUND TO COMPLY WITH THE REQUIREMENTS FOR PRODUCT RELEASE . ACCORDING TO THE PHOTO PROVIDED, THE SYRINGE IS ALREADY IN THE STATE OF WHERE THE NEEDLE IS CONNECTED. BASED ON THE PHOTO ALONE, THE LACK OF PRODUCT TO EXAMINE, AND THE LIMITED INFORMATION AVAILABLE, WE WERE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED ISSUE. THEREFORE, THE ROOT CAUSE REMAINS UNCONFIRMED. AS OF 12DEC2024, (B)(4).PIECES HAVE BEEN DISTRIBUTED FROM THIS LOT, WITH NO OTHER SIMILAR COMPLAINTS REPORTED.

    Description of Event or Problem · 0

    PATIENT REPORTED OBSERVING A VISIBLE DROP OF LIQUID IN THE BARREL OF THE SYRINGE, AND HE IS CONCERN THAT IT COULD POSSIBLY HAVE BACTERIAL CONTAMINATION. PRODUCT WAS NOT USED, NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2164846 TANDEM DIABETES 3ML LL SYR WITH CO-PACKED NEEDLE 26GX3/8'' SYRINGE WITH NEEDLE FMF EXELINT INTERNATIONAL, CO. 220611

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown