BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SVS LLC

    MDR report key: 22734540 · Received August 6, 2025

    Report

    Report Number
    1314417-2025-00025
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Report Date
    August 6, 2025
    Manufacturer
    SUNMED HOLDINGS LLC
    Product Code
    KZD
    UDI-DI
    00818566019653
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION-INVESTIGATION CONCLUSION: D4; H2; H6. THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED FOR EVALUATION; ADDITIONALLY, NO PHOTOGRAPHIC /VIDEO EVIDENCE WAS PROVIDED. THE SUPPLIER PERFORMED COSMETIC AND FUNCTIONAL INSPECTION ON THE RETAINED SAMPLES; NO ISSUES WERE IDENTIFIED. IT WAS NOTED THAT IF THE STOPCOCK IS NOT TURNED TO A SPECIFIC POSITION, IT MAY FAIL TO MAINTAIN PRESSURE DURING USE. THE ROOT CAUSE COULD NOT BE DETERMINED THE DEVICE HISTORY RECORD FOR LOT 240800529 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 06 AUG 2025 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY. FDA INITIAL MW REPORT MW 1314417-2025-00025_(B)(4) _ SUBMITTED TO FDA ON 29APR2025: CORE ID: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED; THE BAG DID NOT HOLD PRESSURE DURING THE PROCEDURE; THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2121448 SVS LLC PREMIERPRO 1000ML PRESSURE INFUSION BAG, MESH BACK KZD SUNMED HOLDINGS LLC 8808 240800529 00818566019653

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown