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 Type  malfunction  

Event Description

On 02/09/2022, alydia health received an email from stating that, "it has been identified that on more than one occasion a jada has been placed, there is no blood seen in the tubing, there is bleeding around the jada, and when the tubing is switched it works.This can mistakenly be identified as a failed jada placement or possible cervical laceration/other source for bleeding." she said that in the most recent case the doctor that was delivering said that jada was placed with the tubing provided, there was bleeding around the seal and no blood in the tubing.She said the tubing was switched and then jada worked.She was uncertain which tubing they switched to, but that she would investigate.She provided not additional information for this case.Request for additional information, questions, possible device retrieval, and lot number availability made to site on 02/09/2022 and 03/09/2022.On (b)(6) 2022 a resident at uh hospitals provided email information regarding this case as she reported an issue with suction tubing while utilizing jada.She stated, "i'm not as familiar with the jada device pieces (and to be honest we were a bit distracted in the or with the hemorrhage), but they did have what appeared to be identical tubing in the or that we utilized to connect the device to the portable suction machine (it was clear tubing with blue pieces on both ends)." she did not provide any additional information or answered any other questions at this time.This report will be amended if additional information is obtained.

Manufacturer Narrative

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.Per the jada system ifu: "evaluate for lacerations, retained products of conception, or other causes of bleeding prior to using jada.", "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."", "check connection on all system components", "confirm vacuum tubing is securely connected at both ends and any connection in between" and "after the vacuum pressure has been set and confirmed, connect jada to the sterile vacuum tubing.Blood flow into the vacuum tubing and/or improvement in uterine tone should be noted after initiation of vacuum.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: 13716836
• MDR Text Key: 289077237
• Report Number: 3017425145-2022-00027
• 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: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• 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: 02/09/2022
• 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