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

Model Number JADA - 1001

Device Problem Loss of or Failure to Bond (1068)

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

Event Date 01/19/2022

Event Type  malfunction  

Manufacturer Narrative

An alydia health employee, executive director, engineering visited the reporting site on february 15, 2022, to examine the jada device in this case.He provided the following investigation.The device was in a biohazard bag and examination of the device was completed without removing the device from the bag, this was done to minimize potential exposure to bloodborne pathogens to both the personnel and office space.Vacuum connection (dr-030, stepped hand pump nozzle) was not present in the bag.The distal end of the device was straightened and examined for any anomalies, none found,.The area around the y-connector was examined and no anomalies were found.A close examination of the connection point for the connector showed the rough appearance of adhesive remnants suggesting that adhesive was used on this joint.There was no sign of damage or trauma to the connection point on the device.The only conclusion that can be drawn is the adhesive attaching the vacuum connector to the device failed.The seal inflation valve was present on the device and no anomalies were noted.The seal of the device was inflated indicating there is not an issue with the seal (balloon) performance.There was no damage to the device other than the missing vacuum connector.There was no sign of tearing or ripping of the silicone around the area where the vacuum connector attaches to the device.Remnants of adhesive at the vacuum connector joint location suggests proper assembly.It appears the adhesive joint failed.Based on the overall information currently provided in this report, there is a reasonable possibility that a potential malfunction (reported as "vacuum connection that is glued to the rubberized arm came apart") has occurred with the jada system.However, it is unlikely that if the suspected malfunction were to recur, would cause or contribute to a death or serious injury given that the hcp would recognize this issue while initiating use of the jada system and would be able to take timely appropriate actions as further supported by the clinical course presented in this case wherein the hcp reportedly replaced the device immediately with another jada system in approximately "10-15 seconds" and the patient's bleeding was reportedly controlled successfully with the second jada system device.However, out of an abundance of caution, this case will be reported as a malfunction mdr.

Event Description

The health care provider (hcp) emailed an alydia health employee stating, "had a problem with a device yesterday.We will be reporting it out.The vacuum connection that is glued to the rubberized arm came apart didn't know if you had any other issues.This seems like a manufacturing issue." in a follow up phone call with the hcp, he confirmed that the date of this event was (b)(6) 2022.He was present for the case and explained that the "vacuum connection that is glued to the rubberized arm came apart." he said that when they attempted to hook the jada device up to suction it "came undone from the rubber tubing" and they were unable to attach the device to the wall suction.He described that they tried to connect the tubing to wall suction and that "torque on connector pulled the glue off." he confirmed the jada device was indwelling for a patient experiencing abnormal postpartum bleeding when this occurred and that they immediately replaced the device with another jada in approximately "10-15 seconds." the patients bleeding was successfully controlled with this second device.The hcp declined to provide patient information for this case.The jada device for this case has been retained and he requested replacement for this device.

• 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: 13560699
• MDR Text Key: 296388789
• Report Number: 3017425145-2022-00011
• 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: Physician
• Type of Report: Initial
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• 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
• Device Lot Number: 1070801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2021
• 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