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 03/03/2022

Event Type  malfunction  

Event Description

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 had pertinent medical history of a multiple (twin) pregnancy, obesity, anemia, and pre-eclampsia.Her pph started within one hour after an induced vaginal delivery.The twins in this case were described as "didi" and twin b required a vaginal breech extraction the amount of blood lost prior to jada use was 1200 ml.Prior to jada treatment she received hemabate (1 unit), txa (1 unit), and cytotec (1 unit, 1000 mcg pr).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 50 ml of blood evacuated with jada.There is no additional 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.

Manufacturer Narrative

Based on the overall information currently provided in this report, there is no clear evidence that the reported circumstance (reported as "200" 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.

• 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: 14018180
• MDR Text Key: 290284418
• Report Number: 3017425145-2022-00053
• 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: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• 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: 03/09/2022
• 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