BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JADA SYSTEM

    MDR report key: 13895630 · Received March 24, 2022

    Report

    Report Number
    3017425145-2022-00042
    Event Type
    Malfunction
    Date Received
    March 24, 2022
    Date of Event
    February 24, 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
    IL, 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 "180" IN THE JADA EXPERIENCE SURVEY FORM PERTAINING TO THE QUESTION ON HOW MUCH STERILE FLUID WAS PLACED IN THE CERVICAL SEAL [IN ML]) 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 180 ML OF STERILE FLUID. THE PATIENT IN THIS CASE HAD NO REPORTED PERTINENT MEDICAL HISTORY. HER PPH STARTED WITHIN ONE TO SIX HOURS AFTER A SPONTANEOUS VAGINAL DELIVERY. THE AMOUNT OF BLOOD LOST PRIOR TO JADA USE WAS 850 ML. PRIOR TO JADA TREATMENT SHE RECEIVED HEMABATE (250 UNITS), CYTOTEC (1000 UNITS), METHERGINE (200 MCG), AND TXA (1000 G). AFTER JADA INSERTION THEY REPORTED FILING THE CERVICAL SEAL WITH 180 ML OF STERILE FLUID, AND THE PATIENTS POSTPARTUM UTERINE BLEEDING WAS CONTROLLED WITHIN ONE TO FIVE MINUTES. THERE WAS 70 ML OF BLOOD EVACUATED WITH JADA. THERE IS NO ADDITIONAL INFORMATION FOR THIS CASE PROVIDED ON THIS SURVEY. 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 SITE FOR THIS CASE RESPONDED THAT THEY DO NOT RECORD LOT NUMBERS AND DID NOT RETAIN THIS DEVICE AS THEY FELT THIS WAS A "JADA SUCCESS." THERE IS NO OTHER INFORMATION THAT WAS PROVIDED FOR THIS CASE BY THIS SITE, A GOOD FAITH EFFORT HAS BEEN MADE TO OBTAIN THIS INFORMATION. THE JADA SYSTEM CERVICAL SEAL WAS FILLED BY THE HEALTH CARE PROVIDER (HCP) IN THIS CASE WITH 180 ML OF STERILE FLUID. THERE WAS NO REPORT OF DEVICE MALFUNCTION OR PATIENT INJURY IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1054365 JADA SYSTEM INTRAUTERINE VACUUM CONTRACTION SYSTEM OQY ALYDIA HEALTH JADA - 1001 00850017882003

    Patients

    Seq Age Sex Outcome Treatment
    1 Female