MAUDE Adverse Event Report: ORGANON & CO. JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 03/01/2023

Event Type  Injury  

Manufacturer Narrative

Based on the information we have received, there is no indication that the device malfunctioned.The device is assembled according to specifications.In process and finished product testing are performed and approved prior to release.

Event Description

Jada was not working [device ineffective] case narrative: this initial spontaneous report originating from the united states, was received from a clinical account specialist (cas) referring to a non-pregnant female patient of an unknown age.The patient's concurrent conditions, medical history, past drug reactions/allergies and concomitant medications were not reported.This report concerns 1 patient and 1 device.On (b)(6) 2023 the patient was inserted with vacuum-induced hemorrhage control system (jada system) via intrauterine route by provider for atony-related bleeding (uterine haemorrhage).Per cas report, the patient had an atony-related bleed and two physicians were working with the patient in the operating room.One provider, placed the vacuum-induced hemorrhage control system (jada system) and felt it was working.The other provider, an attending physician, felt the vacuum-induced hemorrhage control system (jada system) was not working (device ineffective) and removed the jada to place a different device (reported as not a different vacuum-induced hemorrhage control system (jada system), another device entirely; type of device unknown).The cas did not have additional details surrounding the event, but states she was informed that the patient was stable when she left the operating room.No additional information was known or available.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.For vacuum-induced hemorrhage control system (jada system), lot number and serial number were not available.Upon internal review the event device ineffective was considered serious due to required intervention.When the lot number is unknown, a technical investigation of the specific manufacturing process which includes review of records associated with a known lot number cannot be performed.Medical device reporting criteria: serious injury.

Manufacturer Narrative

Based on the information we have received, there is no indication that the device malfunctioned.The device is assembled according to specifications.In process and finished product testing are performed and approved prior to release.

Event Description

Jada was not working [device ineffective] case narrative: this initial spontaneous report originating from the united states, was received from a physician via clinical account specialist (cas) referring to a non-pregnant female patient of an unknown age.The patient's concurrent conditions, medical history, past drug reactions/allergies and concomitant medications were not reported.This report concerns 1 patient and 1 device.On (b)(6) 2023, the patient was inserted with vacuum-induced hemorrhage control system (jada system) via intrauterine route by provider for atony-related bleeding (uterine haemorrhage).Per cas report, the patient had an atony-related bleed, and two physicians were working with the patient in the operating room.One provider placed the vacuum-induced hemorrhage control system (jada system) and felt it was working.The other provider, an attending physician, felt the vacuum-induced hemorrhage control system (jada system) was not working (device ineffective) and removed the vacuum-induced hemorrhage control system (jada system) to place a different device (reported as not a different vacuum-induced hemorrhage control system (jada system), another device entirely; type of device unknown).The cas did not have additional details surrounding the event, but stated she was informed that the patient was stable when she left the operating room.No additional information was known or available.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.For vacuum-induced hemorrhage control system (jada system), lot number and serial number were not available.Upon internal review the event device ineffective was considered serious due to required intervention.When the lot number is unknown, a technical investigation of the specific manufacturing process which includes review of records associated with a known lot number cannot be performed.Medical device reporting criteria: serious injury.Fda code: (health effects - health impact per annex f): 4642 additional device required (use of an additional or alternative device require to achieve optimal outcome.) fda code: (health effects - health impact per annex f): 4648 insufficient information (there is not yet enough information available to classify the health impact.) this is an amended report.The physician was considered as primary reporter and case was made hcp confirmed.Narrative was corrected to reflect the same.Product problem check box was checked.

• Brand Name: JADA SYSTEM
• Type of Device: INTRAUTERINE VACUUM CONTRACTION SYSTEM
• Manufacturer (Section D): ORGANON & CO.; 30 hudson street; jersey city NJ 07302
• Manufacturer (Section G): ORGANON & CO.; 30 hudson street; jersey city NJ 07302
• Manufacturer Contact: 30 hudson street; jersey city, NJ 07302
• MDR Report Key: 16616261
• MDR Text Key: 312010907
• Report Number: 3002806821-2023-00031
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 510K K201199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female