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

Lot Number 1070334

Device Problems Inflation Problem (1310); Leak/Splash (1354); Mechanical Problem (1384); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Low Blood Pressure/ Hypotension (1914)

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

Blood pressure dropped 71/42 [blood pressure decreased].Serosanguinous fluid was coming out around jada/leaking [device leakage].Clots were expressed [device occlusion].Ears muffled [hypoacusis].Felt like she was going to pass out [dizziness].Just some discomfort [discomfort].Only 60 ml of fluid remained, appeared to be defective [device defective].Case narrative: this initial spontaneous report originating from the united states was received from a "or" inventory control lead via clinical account specialist (cas) referring to a female patient of unknown age.The patient's concurrent conditions, concomitant medications, medical history, and past drug reactions/allergies were not reported.This report concerns 1 patient and 1 device.On an unknown date, the patient was inserted with vacuum-induced hemorrhage control system (jada system) (lot# 1070334 and expiry date was not reported; item number was reported as jada-2001) by healthcare professional for an unknown indication.Vacuum-induced hemorrhage control system (jada system) was placed with 100 ml of fluid placed.The patient called out and stated she did not feel right, ears muffled (hypoacusis) and felt like she was going to pass out (dizziness), blood pressure dropped 71/42 (unit not reported) (blood pressure decreased).Upon assessment it was noted that serosanguinous fluid was coming out around vacuum-induced hemorrhage control system (jada system) (device leakage).The physician was at bedside to assess, and vacuum-induced hemorrhage control system (jada system) was taken out, when deflated it was noted that only 60 ml of fluid remained, appeared to be defective (device defective) and leaking.It was reported that patient was doing well just some discomfort.The clots were expressed (device occlusion) and new vacuum-induced hemorrhage control system (jada system) was placed.The cas asked if they could get a replacement at no-cost since the unit was defective.The defective unit was not available for retrieval.The outcome of events hypoacusis, blood pressure decreased, and dizziness was considered as recovering, it was unknown for discomfort.The reporter's causality assessment was not provided.Upon internal review, the events of device leakage and device occlusion were considered to be serious due to required intervention.Upon internal review, the event of blood pressure decreased was considered to be medically significant.Medical device reporting criteria: serious injury.Fda code: (health effects - health impact per annex f): 4641 unexpected medical intervention (patient required an unforeseen medical intervention, excluding surgery, which was not on the original treatment plan.).

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

Blood pressure dropped 71/42 [blood pressure decreased].Serosanguinous fluid was coming out around jada/leaking [device leakage].Clots were expressed [device occlusion].Ears muffled [hypoacusis].Felt like she was going to pass out [dizziness].Just some discomfort [discomfort].Only 60 ml of fluid remained, appeared to be defective [device defective].Case narrative: this initial spontaneous report originating from the united states was received from a "or" inventory control lead via clinical account specialist (cas) referring to a female patient of unknown age.The patient's concurrent conditions, concomitant medications, medical history, and past drug reactions/allergies were not reported.This report concerns 1 patient and 1 device.On an unknown date, the patient was inserted with vacuum-induced hemorrhage control system (jada system) (lot#: 1070334 and expiry date was not reported; item number was reported as jada-2001) by healthcare professional for an unknown indication.Vacuum-induced hemorrhage control system (jada system) was placed with 100 ml of fluid placed.The patient called out and stated she did not feel right, ears muffled (hypoacusis) and felt like she was going to pass out (dizziness), blood pressure dropped 71/42 (unit not reported) (blood pressure decreased).Upon assessment it was noted that serosanguinous fluid was coming out around vacuum-induced hemorrhage control system (jada system) (device leakage).The physician was at bedside to assess, and vacuum-induced hemorrhage control system (jada system) was taken out, when deflated it was noted that only 60 ml of fluid remained, appeared to be defective (device defective) and leaking.It was reported that patient was doing well just some discomfort.The clots were expressed (device occlusion) and new vacuum-induced hemorrhage control system (jada system) was placed.The cas asked if they could get a replacement at no-cost since the unit was defective.The defective unit was not available for retrieval.The outcome of events hypoacusis, blood pressure decreased, and dizziness was considered as recovering, it was unknown for discomfort.The reporter's causality assessment was not provided.Upon internal review, the events of device leakage and device occlusion were considered to be serious due to required intervention.Upon internal review, the event of blood pressure decreased was considered to be medically significant.This is the final report.Complaint sample is not available for investigation.Review elements of the event included lot record package (dhr), non-conformances, manufacturing controls, capa log and complaint trends.The device is assembled per specifications where in-process and final inspections are conducted by trained personnel.In process and finished product testing is performed and approved prior to release.Based on the information received, there is no indication that the device malfunctioned.If the complaint sample becomes available, this complaint will be re-opened and additional investigation may be performed.Medical device reporting criteria: serious injury.Fda code: (health effects - health impact per annex f): 4641 unexpected medical intervention (patient required an unforeseen medical intervention, excluding surgery, which was not on the original treatment plan).

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

Blood pressure dropped 71/42 [blood pressure decreased], serosanguinous fluid was coming out around jada/leaking [device leakage], clots were expressed [device occlusion], ears muffled [hypoacusis], felt like she was going to pass out [dizziness], just some discomfort [discomfort], only 60 ml of fluid remained, appeared to be defective [device defective].Case narrative: this initial spontaneous report originating from the united states was received from a "or" inventory control lead via clinical account specialist (cas) referring to a female patient of unknown age.The patient's concurrent conditions, concomitant medications, medical history, and past drug reactions/allergies were not reported.This report concerns 1 patient and 1 device.On an unknown date, the patient was inserted with vacuum-induced hemorrhage control system (jada system) (lot# 1070334 and expiry date was not reported; item number was reported as jada-2001) by healthcare professional for an unknown indication.Vacuum-induced hemorrhage control system (jada system) was placed with 100 ml of fluid placed.The patient called out and stated she did not feel right, ears muffled (hypoacusis) and felt like she was going to pass out (dizziness), blood pressure dropped 71/42 (unit not reported) (blood pressure decreased).Upon assessment it was noted that serosanguinous fluid was coming out around vacuum-induced hemorrhage control system (jada system) (device leakage).The physician was at bedside to assess, and vacuum-induced hemorrhage control system (jada system) was taken out, when deflated it was noted that only 60 ml of fluid remained, appeared to be defective (device defective) and leaking.It was reported that patient was doing well just some discomfort.The clots were expressed (device occlusion) and new vacuum-induced hemorrhage control system (jada system) was placed.The cas asked if they could get a replacement at no-cost since the unit was defective.The defective unit was not available for retrieval.The outcome of events hypoacusis, blood pressure decreased, and dizziness was considered as recovering, it was unknown for discomfort.The reporter's causality assessment was not provided.Upon internal review, the events of device leakage and device occlusion were considered to be serious due to required intervention.Upon internal review, the event of blood pressure decreased was considered to be medically significant.Medical device reporting criteria: serious injury.Fda code: (health effects - health impact per annex f): 4641 unexpected medical intervention (patient required an unforeseen medical intervention, excluding surgery, which was not on the original treatment plan.).

• 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: 16714365
• MDR Text Key: 313169936
• Report Number: 3002806821-2023-00036
• 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: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 1070334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• 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; Other
• Patient Sex: Female