BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JADA SYSTEM

    MDR report key: 22847834 · Received August 20, 2025

    Report

    Report Number
    3002806821-2025-00070
    Event Type
    Injury
    Date Received
    August 20, 2025
    Date of Event
    August 13, 2025
    Report Date
    January 1, 2026
    Manufacturer
    ORGANON LLC
    Product Code
    OQY
    UDI-DI
    00840164521139
    PMA / PMN Number
    K212757
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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. COMPLAINT DESCRIPTION NOTES THE NURSE WHO WAS ASSISTING WITH SETTING JADA UP, HOOKED THE SUCTION FOR IT INCORRECTLY AND PROLONGED THE PATIENT'S BLEEDING. THE SUCTION TUBING WAS CONNECTED TO THE REGULATOR ON THE WALL INSTEAD OF THE CANNISTER (WRONG TECHNIQUE IN DEVICE USAGE PROCESS). THIS SUCTION ISSUE WAS TROUBLESHOOTED AND CORRECTED. THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WORKED FOR THE PATIENT AND CONTROLLED THE BLEEDING. ADDITIONALLY, LOT NUMBER AND EXPIRY WERE NOT REPORTED AND THE DEVICE WAS NOT RETURNED. COMPLAINT DESCRIPTION SUMMARY: AE QIR UTERINE ARTERY EMBOLIZATION. WRONG TECHNIQUE IN DEVICE USAGE PROCESS. BASED ON MDCP-TO REVIEW, MANUFACTURING INVESTIGATION NOT REQUIRED THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.

    Additional Manufacturer Narrative · 0

    THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION WE HAVE RECEIVED, THERE IS NO INDICATION THAT THE DEVICE MALFUNCTIONED. THE DEVICE IS ASSEMBLED ACCORDING TO SPECIFICATIONS. IN PROCESS AND FINISHED PRODUCT TESTING ARE PERFORMED AND APPROVED PRIOR TO RELEASE.

    Description of Event or Problem · 0

    FOLLOW UP RECEIVED ON 28-DEC-2025. EXTENSION REQUEST SUBMITTED FOR APPROVAL. COMPLAINT DESCRIPTION NOTES THE NURSE WHO WAS ASSISTING WITH SETTING VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) UP, HOOKED THE SUCTION FOR IT INCORRECTLY AND PROLONGED THE PATIENT'S BLEEDING. THE SUCTION TUBING WAS CONNECTED TO THE REGULATOR ON THE WALL INSTEAD OF THE CANNISTER (WRONG TECHNIQUE IN DEVICE USAGE PROCESS). THIS SUCTION ISSUE WAS TROUBLESHOOTED AND CORRECTED. THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WORKED FOR THE PATIENT AND CONTROLLED THE BLEEDING. ADDITIONALLY, LOT NUMBER AND EXPIRY WERE NOT REPORTED AND THE DEVICE WAS NOT RETURNED. COMPLAINT DESCRIPTION SUMMARY: AE QIR UTERINE ARTERY EMBOLIZATION. WRONG TECHNIQUE IN DEVICE USAGE PROCESS. BASED ON MDCP-TO REVIEW, MANUFACTURING INVESTIGATION NOT REQUIRED.

    Description of Event or Problem · 0

    THIS IS AN AMENDED REPORT: ADDED SERIOUSNESS CRITERIA FOR EVENT UTERINE ARTERY EMBOLIZATION AS 'MEDICALLY SIGNIFICANT'. ADDED 'THE UTERINE ATONY WAS THE SUSPECTED CAUSE OF POSTPARTUM HEMORRHAGE' IN THE NARRATIVE. UPDATED NARRATIVE FROM ¿THE BLOOD WAS STAYED IN THE TUBING¿ TO ¿THE BLOOD STAYED IN THE TUBING¿. REMOVED RECEIVED FROM DPOC FROM REFERENCES.

    Description of Event or Problem · 0

    UTERINE ARTERY EMBOLIZATION. THE NURSE ASSISTING WITH SETTING IT UP HOOKED THE SUCTION FOR IT INCORRECTLY/THE SUCTION TUBING WAS CONNECTED TO THE REGULATOR ON THE WALL INSTEAD OF THE CANNISTER/SUCTION ISSUE [WRONG TECHNIQUE IN DEVICE USAGE PROCESS]. CASE NARRATIVE: THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES WAS RECEIVED FROM A NURSE EDUCATOR REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE VIA COMPANY REPRESENTATIVE (TERRITORY MANAGER). THE PATIENT HAD A SINGLETON PREGNANCY AND GAVE LIVE BIRTH VIA VAGINAL DELIVERY AT TERM (EXACT GESTATIONAL AGE WAS UNKNOWN). THE PLACENTA WAS RETAINED SO THE HEALTH CARE PROFESSIONAL (HCP) HAD TO MANUALLY REMOVE THE PLACENTA; A BANJO WAS USED AT THE BEDSIDE AND BIMANUAL MASSAGE WAS GIVEN. THE PATIENT HAD 4 GRAVIDITY (G) AND 3 PARITY (P). THIS REPORT CONCERNS 1 PATIENT(S) AND 1 DEVICE(S). ON (B)(6) 2025, THE PATIENT WAS PLACED WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) 2002 VIA VAGINAL ROUTE (LOT # AND EXPIRATION DATE WERE NOT REPORTED) FOR POST PARTUM HEMORRHAGE. THE OPERATOR WAS NOT FIRST TIME USING THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM). THE OPERATOR RECEIVED TRAINING ON HOW TO USE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) IN NOVEMBER 2022. THE NURSE WHO WAS ASSISTING WITH SETTING IT UP, HOOKED THE SUCTION FOR IT INCORRECTLY AND PROLONGED THE PATIENT'S BLEEDING. THE SUCTION TUBING WAS CONNECTED TO THE REGULATOR ON THE WALL INSTEAD OF THE CANNISTER (WRONG TECHNIQUE IN DEVICE USAGE PROCESS). THIS SUCTION ISSUE WAS TROUBLESHOOTED AND CORRECTED. THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WORKED FOR THE PATIENT AND CONTROLLED THE BLEEDING. THE BLOOD WAS STAYED IN THE TUBING AND WAS NOT COLLECTED IN THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) CANISTER. THE PATIENT DID NOT REQUIRE MATERNAL ADMISSION TO INTENSIVE CARE UNIT (ICU). NOT MORE THAN ONE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) DEVICE USED. THE PATIENT WAS LATER SENT TO INTERVENTIONAL RADIOLOGY FOR UTERINE ARTERY EMBOLIZATION (UTERINE ARTERY EMBOLISATION). SHE HAS NO FURTHER DETAILS TO REPORT. AFTER INITIAL BLEEDING CONTROL BY VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM), ANOTHER BLEEDING EPISODE WAS NOT THERE (DISCREPANT INFORMATION: THE PATIENT REQUIRED UTERINE ARTERY EMBOLIZATION AFTER VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) USED TO CONTROL THE ABNORMAL POSTPARTUM UTERINE BLEEDING). THE PATIENT WAS NOT DIAGNOSED WITH ENDOMETRITIS. THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) DEVICE WAS NOT REMOVED AND REINSERTED FOR ANY REASON. THE ULTRASOUND WAS NOT USED AT ANY POINT TO EVALUATE DURING VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) USE. THE PATIENT RECOVERED FROM UTERINE ARTERY EMBOLISATION ON (B)(6) 2025. THE REPORTER'S CAUSALITY ASSESSMENT WAS NOT REPORTED. UPON INTERNAL REVIEW, THE EVENT UTERINE ARTERY EMBOLISATION WAS CONSIDERED TO BE SERIOUS AS REQUIRED INTERVENTION (DEVICES). WHEN THE LOT NUMBER IS UNKNOWN, A TECHNICAL INVESTIGATION OF THE SPECIFIC MANUFACTURING PROCESS WHICH INCLUDES REVIEW OF RECORDS ASSOCIATED WITH A KNOWN LOT NUMBER CANNOT BE PERFORMED. MEDICAL DEVICE REPORTING CRITERIA: SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1144170 JADA SYSTEM INTRAUTERINE VACUUM CONTRACTION SYSTEM OQY ORGANON LLC JADA-2002 00840164521139

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| O