BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JADA SYSTEM

    MDR report key: 23004443 · Received September 9, 2025

    Report

    Report Number
    3002806821-2025-00072
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Report Date
    April 21, 2026
    Manufacturer
    ORGANON LLC
    Product Code
    OQY
    UDI-DI
    00840164521139
    PMA / PMN Number
    K212757
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MODEL NUMBER INFORMATION WAS NOT REPORTED OR NOT KNOWN BY THE REPORTER. HENCE, WE CANNOT DEFINITIVELY DETERMINE THE MODEL WITH THE INFORMATION PROVIDED. MODEL 2 WAS SELECTED AS THERE IS A MUCH HIGHER PROBABILITY THAT THIS MODEL WAS USED AS ORGANON IS CURRENTLY ONLY MANUFACTURING/MARKETING THIS MODEL. NO COMPLAINT SAMPLE WAS AVAILABLE FOR EVALUATION. REPORTED LOT: 1121101 DURING INCOMING INSPECTION AT THE EXTERNAL PARTY MANUFACTURER, THE COMPONENT (TUBING) PASSED RELEASE CRITERIA DURING INCOMING QUALITY INSPECTIONS. NO OBSERVATION OF A DAMAGED CONNECTOR WAS DOCUMENTED BY EXTERNAL PARTY MANUFACTURER DURING THE PACKAGING PROCESS. THE PRODUCT (TUBING) WAS MANUFACTURED IN ACCORDANCE WITH CURRENT DESIGN SPECIFICATIONS AND CURRENT PRODUCTION PROCESSES AND HAS MET ALL QUALITY ASSURANCE CRITERIA. IT WAS POSSIBLE A DAMAGED TUBE COULD HAVE BEEN PRESENT WITHIN THE PACKAGE AS PROVIDED BY THE TUBING SUPPLIER. THIS DEFECT WAS WITHIN THE INSPECTION ACCEPT/REJECT CRITERIA.

    Description of Event or Problem · 0

    AIR LEAKING FROM THE TUBING THAT CAME IN THE KIT [DEVICE LEAKAGE]. NO ADDITIONAL AE REPORTED [NO ADVERSE EVENT]. CASE NARRATIVE: THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES WAS RECEIVED FROM A CERTIFIED MIDWIFE REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE VIA CLINICAL ACCOUNT SPECIALIST (CAS). THE PATIENT'S MEDICAL HISTORY, CURRENT CONDITIONS, CONCOMITANT MEDICATIONS AND PAST DRUG REACTIONS/ALLERGIES WERE NOT REPORTED. THIS REPORT CONCERNS 1 PATIENT(S) AND 1 DEVICE(S). ON (B)(6) 2025 (ALSO REPORTED AS YESTERDAY), THE PATIENT WAS PLACED WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) 2.0 VIA VAGINAL ROUTE (LOT#: 1121101 HAD BEEN VERIFIED TO BE A VALID LOT NUMBER FOR VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) AND THE EXPIRATION DATE WAS NOT REPORTED, BUT UPON INTERNAL VALIDATION, IT WAS ESTABLISHED AS 11-SEP-2026) (SERIAL# WAS NOT REPORTED) FOR POSTPARTUM HEMORRHAGE. AFTER PLACING THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) THE MIDWIFE COULD HEAR AIR LEAKING FROM THE TUBING THAT CAME IN THE KIT (DEVICE LEAKAGE). THEY COULD ALSO SEE AIR MIXING WITH THE BLOOD IN THE TUBING. THERE WAS NO VISUAL DAMAGE TO THE TUBING AND THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WORKED FINE ONCE THE TUBING WAS CHANGED. NO ADDITIONAL ADVERSE EVENT (AE) (NO ADVERSE EVENT) REPORTED. THIS IS AN INTERNAL LOT NUMBER VALIDATION PERFORMED FOR LOT#: 1121101. FOLLOW UP REPORT WAS RECEIVED FROM QUALITY INVESTIGATION TEAM ON 23-JUN-2025. ADDED IMDRF CODES. FOLLOW-UP INFORMATION HAS BEEN RECEIVED FROM THE QUALITY INVESTIGATION TEAM ON 03-SEP-2025. THIS IS A FINAL REPORT. MANUFACTURING STATEMENT: NO COMPLAINT SAMPLE WAS AVAILABLE FOR EVALUATION. REPORTED LOT: 1121101 DURING INCOMING INSPECTION AT THE EXTERNAL PARTY MANUFACTURER, THE COMPONENT (TUBING) PASSED RELEASE CRITERIA DURING INCOMING QUALITY INSPECTIONS. NO OBSERVATION OF A DAMAGED CONNECTOR WAS DOCUMENTED BY EXTERNAL PARTY MANUFACTURER DURING THE PACKAGING PROCESS. THE PRODUCT (TUBING) WAS MANUFACTURED IN ACCORDANCE WITH CURRENT DESIGN SPECIFICATIONS AND CURRENT PRODUCTION PROCESSES AND HAS MET ALL QUALITY ASSURANCE CRITERIA. IT WAS POSSIBLE A DAMAGED TUBE COULD HAVE BEEN PRESENT WITHIN THE PACKAGE AS PROVIDED BY THE TUBING SUPPLIER. THIS DEFECT WAS WITHIN THE INSPECTION ACCEPT/REJECT CRITERIA. CASE COMMENTS: BASED ON DETAILS FROM COMPLAINTS, THE FAILURE MODE APPEARS TO BE THE VACUUM TUBING FROM THE KIT ACCESSORY SINCE 'HEAR OF AIR LEAKING AND SEE AIR MIXED WITH THE BLOOD IN THE TUBING' WAS REPORTED. IN ADDITION, 'THERE WAS NO VISUAL DAMAGE TO THE TUBING AND THE JADA WORKED FINE ONCE THE TUBING WAS CHANGE' REPORTED INDICATED THAT THE JADA DEVICE WAS OPERATIONAL. VACUUM TUBING INFORMATION WILL BE PROVIDED TO THE SUPPLIER FOR INVESTIGATION. BASED ON THE CLINICALLY RELEVANT INFORMATION CURRENTLY AVAILABLE FOR THIS INDIVIDUAL CASE AND THE US DECISION TREE (DEVICE ONLY), THE CASE WAS CONSIDERED NOT REPORTABLE, SINCE THE INFORMATION DID NOT REASONABLY SUGGEST THAT THE PRODUCT MAY HAVE CAUSED/CONTRIBUTED TO OR LIKELY TO CAUSE/CONTRIBUTE TO DEATH OR ANY OF THE OTHER SERIOUS INJURIES/OUTCOMES OR NEEDED ANY ADDITIONAL MEDICAL OR SURGICAL INTERVENTION BEYOND WHAT IS NORMALLY REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308925 JADA SYSTEM INTRAUTERINE VACUUM CONTRACTION SYSTEM OQY ORGANON LLC JADA-2002 1121101 00840164521139

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female