BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JADA SYSTEM

    MDR report key: 25300684 · Received May 27, 2026

    Report

    Report Number
    3002806821-2026-00007
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Report Date
    May 27, 2026
    Manufacturer
    ORGANON LLC
    Product Code
    OQY
    PMA / PMN Number
    K212757
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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. THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.

    Description of Event or Problem · 0

    SHE SAID THE BALLOON IN THE FIRST ONE WOULD NOT INFLATE AT ALL AFTER MULTIPLE SYRINGES WERE ATTEMPTED WITHOUT SUCCESS. [DEVICE ISSUE]. CASE NARRATIVE: THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES WAS RECEIVED FROM A REGISTERED NURSE (RN) REFERRING TO A FEMALE PATIENT OF AN UNKNOWN AGE VIA FIELD BASED AGENT (FBE). THE PATIENT'S MEDICAL HISTORY, CONCURRENT CONDITION, CONCOMITANT MEDICATION, PAST DRUG/ALLERGY WERE NOT REPORTED. THIS REPORT CONCERNS 1 PATIENT(S) AND 1 DEVICE(S). ON (B)(6) 2026 (ALSO REPORTED ON YESTERDAY), THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) DEVICE WAS PLACED VIA VAGINAL ROUTE (DEFAULTED) (LOT NUMBER REPORTED AS 1157201 AND EXPIRATION DATE WAS REPORTED AS 22-JUL-2028) FOR UNKNOWN INDICATION. ON (B)(6) 2026, THE PATIENT HAD USED VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) AND ULTIMATELY HAD TO OPEN A SECOND UNIT. THE NURSE TOLD THAT, BALLOON IN THE FIRST ONE WOULD NOT INFLATE AT ALL AFTER MULTIPLE SYRINGES WERE ATTEMPTED WITHOUT SUCCESS (DEVICE ISSUE), THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) UNIT WAS DISCARDED. FOLLOW UP INFORMATION RECEIVED FROM A REGISTERED NURSE (RN) ON (B)(6) 2026 REFERRING TO 34-YEARS-OLD PATIENT. THE PATIENT DELIVERED THE BABY AT 36 WEEKS OF GESTATION. TOTAL BLOOD LOSS WAS 300 MILLILITER (ML) AT DELIVERY. THE PATIENT RECEIVED 1000 OF CYTOTEC, 1 GRAMS (GM) TRANEXAMIC ACID (TXA), 30 UNITS AND 500 OF OXYTOCIN (PITOCIN), ADDITIONAL 1 GM TRANEXAMIC ACID (TXA), AND ADDITIONAL 10 UNIT OF INTRAMUSCULAR (IM) OXYTOCIN (PITOCIN). SOURCE OF UTERINE BLEEDING FOUND TO BE UTERINE ARTERY BLEED AS OPPOSED TO UTERINE ATONY. THE PATIENT DID NOT HAVE ANY COAGULATION/CLOTTING DISORDER. THIS IS ONE OF TWO REPORTS CONCERNING THE SAME PATIENT, REPORTED BY THE SAME REPORTER. THIS IS AN AMENDMENT REPORT: UPDATED DEVICE MALFUNCTION FIELD. CASE COMMENTS: BASED ON THE CLINICALLY RELEVANT INFORMATION CURRENTLY AVAILABLE FOR THIS INDIVIDUAL CASE AND THE FDA DECISION TREE, THE CASE WAS CONSIDERED REPORTABLE. THE MALFUNCTION LIKELY TO CAUSE OR CONTRIBUTE TO DEATH/SERIOUS INJURY, SHOULD IT RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344017 JADA SYSTEM INTRAUTERINE VACUUM CONTRACTION SYSTEM OQY ORGANON LLC JADA-2002 1157201

    Patients

    Seq Age Sex Outcome Treatment
    1