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

Model Number JADA 1001

Device Problems Component Incompatible (1108); Component or Accessory Incompatibility (2897); Compatibility Problem (2960)

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

Event Date 04/08/2022

Event Type  malfunction  

Event Description

This spontaneous report was received from a physician via a health care professional and a company representative, referring to a female patient of unknown age.This report concerns 1 device and 1 patient.The patient's past medical history, concurrent conditions and concomitant medications were not reported.On (b)(6) 2022, a complaint was received regarding vacuum-induced hemorrhage control system (jada system).It stated that on (b)(6) 2022, "luer lock separated from end of catheter when inflating; needed to be held on with tape" (device issue).The device lot number was reported on the device complaint as 1070802 (expiration date not reported).It was currently unknown if the device was retained.A follow up request to the site was made regarding device retention and additional details of this case.It was reported that the event caused hospitalization and an intervention was required.Medical device reporting criteria: malfunction (b)(4).No health consequences or impact (no apparent harm occurred in relation to the adverse event).

Manufacturer Narrative

This report represents a potential malfunction.The device is assembled according to specifications.In process and finished product testing are performed and approved prior to release.The investigation is currently ongoing; a follow up report will be submitted upon completion of the investigation.

Event Description

This spontaneous report was received from a physician via a healthcare professional and a company representative, referring to a female patient of unknown age.This report concerns 1 device and 1 patient.The patient's past medical history, concurrent conditions and concomitant medications were not reported.On 12-apr-2022, a complaint was received regarding vacuum-induced hemorrhage control system (jada system).It stated that on (b)(6) 2022, "luer lock separated from end of catheter when inflating; needed to be held on with tape" (device issue).The device lot number was reported on the device complaint as (b)(4) (expiration date not reported).It was currently unknown if the device was retained.A follow up request to the site was made regarding device retention and additional details of this case.The event of device issue was determined to be medically significant.This is the final report.Executive summary: medical device reporting (mdr) had been reported for this event.A complaint sample was not provided by the complainant.The lot number reported for the vacuum-induced hemorrhage control system (jada system) 1 device was 1070802.No aberrations to the process were noted during device history record review by the device manufacturer.A potential failure of the luer-lock valve can be produced if the luer lock syringe is twisted into the inflation valve instead of inserted directly.To disassemble the resulting stuck syringe requires it to be forcefully removed, bringing the inflation valve with it.To reduce the likelihood of this failure mode occurring, a design change for vacuum-induced hemorrhage control system (jada system) 2 occurred which changed the luer connection configuration and dimensions which aim to create stronger assembly connections.Medical device reporting criteria: malfunction fda code (health effects - health impact code annex f): 2199 no health consequences or impact (no apparent harm occurred in relation to the adverse event.).

Manufacturer Narrative

Mdr has been reported for this event.A complaint sample was not provided by the complainant.The lot number reported for the jada 1 device is 1070802.No aberrations to the process were noted during device history record review by the device manufacturer.A potential failure of the luer-lock valve can be produced if the luer lock syringe is twisted into the inflation valve instead of inserted directly.To disassemble the resulting stuck syringe requires it to be forcefully removed, bringing the inflation valve with it.To reduce the likelihood of this failure mode occurring, a design change for jada 2 occurred which changed the luer connection configuration and dimensions which aim to create stronger assembly connections.

• 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; menlo park CA 94025
• Manufacturer Contact: heather wisler ; 3495 edison way; menlo park; menlo park, CA 94025 ; 8445232666
• MDR Report Key: 14431352
• MDR Text Key: 300303061
• Report Number: 3017425145-2022-00092
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JADA 1001
• Device Catalogue Number: JADA 1001
• Device Lot Number: 1070802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2022
• 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 Outcome(s): Other
• Patient Sex: Female