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

Model Number JADA - 1001

Device Problem Suction Failure (4039)

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

Event Date 02/14/2022

Event Type  malfunction  

Event Description

Alydia health received a jada experience survey (jes) on 02/15/2022, that had a handwritten statement in the area designated for 'what treatment(s) did you use to treat the abnormal postpartum uterine bleeding that was not controlled with the jada system?' that stated, "had to use a 2nd jada b/c 1st was broken suction and kept coming loose." the patient in this case is described as having a history of anemia, obesity and multiparous.She had a scheduled cesarean section (c-section) delivery and her abnormal postpartum uterine bleeding or pph started within one hour after delivery.Prior to jada treatment she received unknown doses of cytotec, hemabate, methergine (two units), and txa.The amount of blood loss prior to jada use was reported as 1000 ml.They report placing a jada device and being unable to successfully use the device because it was "broken and coming loose." they removed this jada and inserted a second device, hooked it up to suction, and reported the patients bleeding stopping in one to five minutes.There is no report of if or how much sterile fluid the cervical seal was filled with.The amount of blood evacuated with the second jada was 100 ml.There is no other information for this case provided on this survey.The health care providers who were in the operating room think the connection port to the suction was loose on the jada device and kept coming disassembled when they would try and reattach the suction.The doctor and nurse said the "defective" jada worked initially but then the suction tubing kept coming loose on the jada.The hcp removed the first jada and placed a second jada that she reported working right away and "just fine for the patient." this site provided the following information: lot # 1070803; mfg.Date 2021-09-03 and expiration date 2025-09-03.

Manufacturer Narrative

Alydia health/organon device expert provided the following analysis for this device following examination of the jada system device pictures the site provided, "the vacuum connector became detached from the device which explains the difficulty they had with maintaining vacuum.Of note is what looks like damage to the silicone where the vacuum connector attaches to the silicone.We have never seen that damage before, and lot release testing of this lot would have visually identified such a defect.We will not know but it is possible the device was damaged sometime between the final assembly and the use of the device.Such damage to the silicone in that area of the device could cause the vacuum connector to dislodge from the device.We should continue to monitor for a repeat of this type of damage to the silicone." based on the overall information currently provided in this report, there is a reasonable possibility that a potential malfunction has occurred with the jada system.However, the likelihood of the suspected malfunction to cause or contribute to a death or serious injury appears to be unlikely if the suspected malfunction were to recur given that the hcp would recognize this issue while initiating use of jada and would be able to take appropriate action.Limited details were provided regarding the occurrence of this event.This report will be amended as appropriate if additional information is received regarding this occurrence.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." and, "check connection on all system components"and "confirm vacuum tubing is securely connected at both ends and any connection in between." out of an abundance of caution, the company will report this case 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: 13794796
• MDR Text Key: 297358457
• Report Number: 3017425145-2022-00033
• 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: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• 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: 1070803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 30 YR
• Patient Sex: Female