BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JADA SYSTEM

    MDR report key: 13892551 · Received March 24, 2022

    Report

    Report Number
    3017425145-2022-00040
    Event Type
    Malfunction
    Date Received
    March 24, 2022
    Date of Event
    February 23, 2022
    Report Date
    March 24, 2022
    Manufacturer
    ALYDIA HEALTH
    Product Code
    OQY
    UDI-DI
    00850017882003
    PMA / PMN Number
    K201199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE OVERALL INFORMATION CURRENTLY PROVIDED IN THIS REPORT, THERE IS NO CLEAR EVIDENCE THAT THE REPORTED CIRCUMSTANCE (REPORTED AS "AFTER JADA INSERTION THEY REPORTED FILING THE CERVICAL SEAL WITH 200 ML OF STERILE FLUID, AND THE PATIENTS POSTPARTUM UTERINE BLEEDING WAS CONTROLLED IN LESS THAN ONE MINUTE") WITH THE JADA SYSTEM HAS CAUSED OR CONTRIBUTED TO THE OCCURRENCE OF A POTENTIAL MALFUNCTION AND/ OR SERIOUS INJURY. THIS REPORT WILL BE AMENDED AS APPROPRIATE IF ADDITIONAL INFORMATION IS RECEIVED. PER THE JADA SYSTEM IFU "JADA PREPARATION; FILL STERILE LUER TAPERED SYRINGE WITH 60 ML OF STERILE FLUID." AND "FILLING OF CERVICAL SEAL AND CONNECTION OF VACUUM: WHILE SECURELY HOLDING THE SEAL VALVE AND AVOIDING UNINTENTIONAL PROXIMAL OR DISTAL MOVEMENT OF THE CERVICAL SEAL AWAY FROM THE EXTERNAL CERVICAL OS, USE A STERILE LUER TAPERED SYRINGE TO FILL THE CERVICAL SEAL WITH 60 ML OF STERILE FLUID. IF NEEDED, ADD UP TO ANOTHER 60 ML OF STERILE FLUID TO ACHIEVE COVERAGE OF THE EXTERNAL CERVICAL OS AND CREATE A SEAL FOR VACUUM." HOWEVER, OUT OF AN ABUNDANCE OF CAUTION, THIS CASE WILL BE REPORTED AS A MALFUNCTION MDR.

    Description of Event or Problem · 0

    ALYDIA HEALTH RECEIVED A JADA EXPERIENCE SURVEY (JES) ON (B)(6) 2022, THAT THE HEALTH CARE PROVIDER (HCP) FILLED THE JADA SYSTEM CERVICAL SEAT WITH 200 ML OF STERILE FLUID. THE PATIENT IN THIS CASE IS DESCRIBED AS HAVING GESTATIONAL HYPERTENSION. HER PPH STARTED WITHIN ONE HOUR AFTER A SCHEDULED CESAREAN SECTION DELIVERY. THE AMOUNT OF BLOOD LOST PRIOR TO JADA USE WAS 1225 ML. PRIOR TO JADA TREATMENT SHE RECEIVED HEMABATE (250 UNITS), CYTOTEC (400 UNITS), METHERGINE (2 UNITS), AND TXA (1000 UNITS). AFTER JADA INSERTION THEY REPORTED FILING THE CERVICAL SEAL WITH 200 ML OF STERILE FLUID, AND THE PATIENTS POSTPARTUM UTERINE BLEEDING WAS CONTROLLED IN LESS THAN ONE MINUTE. THERE WAS 10 ML OF BLOOD EVACUATED WITH JADA. THERE IS NO OTHER INFORMATION FOR THIS CASE PROVIDED ON THIS SURVEY. THERE WAS NO REPORT OF PATIENT INJURY OR ADDITIONAL TREATMENT REQUIRED FOR THIS PATIENT. THERE WAS NO REPORT OF DEVICE MALFUNCTION FOR THIS CASE. THERE IS LIMITED INFORMATION FOR THIS JES CURRENTLY. A REQUEST FOR ADDITIONAL INFORMATION WAS MADE ON (B)(6) 2022, TO INQUIRE IF THE LOT NUMBER WAS AVAILABLE, IF THE DEVICE WAS RETAINED, AND FOLLOW UP QUESTIONS REGARDING THIS CASE. THE RESPONSE TO THIS REQUEST ON (B)(6) 2022 WAS THAT THE HCP WILL NOT PROVIDE ANY ADDITIONAL INFORMATION ON THIS CASE AND DOES NOT WANT ANY FURTHER FOLLOW UP OR CONTACT AND WANTS TO REMAIN ANONYMOUS REGARDING THIS JADA EXPERIENCE SURVEY. A GOOD FAITH EFFORT TO OBTAIN A LOT NUMBER HAS BEEN ATTEMPTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367604 JADA SYSTEM INTRAUTERINE VACUUM CONTRACTION SYSTEM OQY ALYDIA HEALTH JADA - 1001 00850017882003

    Patients

    Seq Age Sex Outcome Treatment
    1 Female