MAUDE Adverse Event Report: ALYDIA HEALTH JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM

Model Number JADA - 1001

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2022

Event Type  malfunction  

Manufacturer Narrative

Based on the overall information currently provided in this report, there is a reasonable possibility that a potential malfunction (reported as "jada was leaking around the seal during fundal assessment") has occurred with the jada system whereby if the suspected malfunction were to recur at a time when the patient was not under close observation, this malfunction could possibly cause or contribute to a death or serious injury.Out of an abundance of caution, the company will report this case as a malfunction mdr.Per the jada system ifu, "signs of patient deterioration or failure to improve indicate the need for reassessment and possibly more aggressive treatment and management of postpartum hemorrhage (pph)/abnormal postpartum uterine bleeding.", "jada is not a substitute for surgical management and fluid resuscitation of life-threatening pph/abnormal postpartum uterine bleeding.", "precautions: after initiation of vacuum, blood flow into jada or the vacuum tubing and/or improvement in uterine tone should be noted.If this does not occur, the cervical seal and/or the vacuum may not be effective.", "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, attach 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" and "note: confirm that the cervical seal is positioned at the external cervical os after the system is in place (cervical seal is filled and the vacuum is connected).Reposition jada if required to facilitate a seal".

Event Description

Alydia health received a report regarding jada use in a case where "jada was leaking around the seal during fundal assessment." the health care provider reports that they filled the seal with an additional 60 ml to a total of 180 ml.She did not have many details about the case but said she thought jada was in place for "about 3 hours and worked well otherwise." the patient in this case was described as having gestational hyper tension and having receied high dose oxytocin "for a long time" and prolonged rupture of membranes.On (b)(6) 2022 her postpartum uterine bleeding started within one hour after an augmented, vacuum assited vaginal delivery, the amount of blood loss prior to jada use was 955 ml.Prio to jada treatment the patient recieved hemabate (800 units) and txa (1000mg).The amount of blood in the jada canister was estimated to be"50 -75 ml." the health care provider did not have the lot number for this device and the faiclity does not record them.A good faith effort was made to obtain this information.

• Brand Name: JADA SYSTEM
• Type of Device: INTRAUTERINE VACUUM CONTRACTION SYSTEM
• Manufacturer (Section D): ALYDIA HEALTH; 3495 edison way; menlo park CA 94025
• Manufacturer (Section G): ALYDIA HEALTH; 3495 edison way; menlo park CA 94025
• Manufacturer Contact: heather wisler ; 3495 edison way; menlo park, CA 94025 ; 8445232666
• MDR Report Key: 14230915
• MDR Text Key: 299375204
• Report Number: 3017425145-2022-00073
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 00850017882003
• UDI-Public: (01)00850017882003
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JADA - 1001
• Device Catalogue Number: JADA-1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female