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

Lot Number UNKNOWN

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

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2024

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

User error /did not sweep [device use error] no new adverse event (ae) (no adverse event) or product quality complaint (pqc) reported.[no adverse event] case narrative: this spontaneous report originating from united states was received from a nurse manager via clinical sales educator (cse), referring to a female patient of unknown age.The patient¿s historical condition, current condition, concomitant medications and past drug reactions/allergies were not reported.This report concerns 1 patient(s) and 3 devices.Over the weekend (09-feb-2024-11-feb-2024), the patient underwent insertion with vacuum-induced hemorrhage control system (jada system) (lot and expiration date were not reported) via intravaginal route for bleeding.The clinical sales educator (cse) spoke with the nurse manager and was given additional information.The nurse manager said it was user error and not quality issue.The physician did not sweep the uterus prior to the insertion (device use error).All 3 devices were discarded.The third vacuum-induced hemorrhage control system (jada system) was inserted which worked and was left in place.The patient was transferred to the intensive care unit (icu) for a short time and then returned to labor and delivery.No additional information provided.No new adverse event (ae) (no adverse event) or product quality complaint (pqc) reported.The patient was sought medical attention.Therapy with vacuum-induced hemorrhage control system (jada system) was withdrawn.The outcome of event device use error was unknown.Upon internal review, the event of device use error was determined to be serious due to due required intervention (devices) and hospitalization.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): 4608 intensive care (patient requires admission to or extension of stay in an intensive care unit).Fda code: (health effects - health impact per annex f): 4607 hospitalization or prolonged hospitalization (hospitalization or prolonged hospitalization due to the health damage accompanying the use of device).

Event Description

User error /did not sweep [device use error] no new adverse event (ae) (no adverse event) or product quality complaint (pqc) reported.[no adverse event] case narrative: this spontaneous report originating from united states was received from a nurse manager via clinical sales educator (cse), referring to a female patient of unknown age.The patient¿s historical condition, current condition, concomitant medications and past drug reactions/allergies were not reported.This report concerns 1 patient(s) and 3 devices.Over the weekend ((b)(6) 2024-(b)(6) 2024), the patient underwent insertion with vacuum-induced hemorrhage control system (jada system) (lot and expiration date were not reported) via intravaginal route for bleeding.The clinical sales educator (cse) spoke with the nurse manager and was given additional information.The patient used 2 or 3 vacuum-induced hemorrhage control system (jada system) over the weekend because she thought they were not working correctly because the patient continued to bleed.The nurse manager said it was user error and not quality issue.The physician did not sweep the uterus prior to the insertion (device use error).All 3 devices were discarded.The third vacuum-induced hemorrhage control system (jada system) was inserted which worked and was left in place.The patient was transferred to the intensive care unit (icu) for a short time and then returned to labor and delivery.No additional information provided.No new adverse event (ae) (no adverse event) or product quality complaint (pqc) reported.The patient was sought medical attention.Therapy with vacuum-induced hemorrhage control system (jada system) was withdrawn.The outcome of event device use error was unknown.Upon internal review, the event of device use error was determined to be serious due to due required intervention (devices).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): 4608 intensive care (patient requires admission to or extension of stay in an intensive care unit).Fda code: (health effects - health impact per annex f): 4607 hospitalization or prolonged hospitalization (hospitalization or prolonged hospitalization due to the health damage accompanying the use of device).This case was linked to same patient linked cases included aer # (b)(4) considered as master case referred as device 2 (device ineffective, device use error and hypotension) and aer #(b)(4) referred to device 1 (device occlusion, device use error).This is an amendment report to check hospitalization prolonged checkbox and event caused hospitalization was unchecked as the patient entry to hospital and she was transferred to icu.Ae onset was updated from 2024 to february 2024.Statement "used 2 or 3 jadas over the weekend because she thought they were not working correctly because the patient continued to bleed." was updated in narrative.Linked cases statement was updated.Hospitalization was removed from seriousness liner since it was not based upon internal review.

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

User error /did not sweep [device use error] no new adverse event (ae) (no adverse event) or product quality complaint (pqc) reported.[no adverse event] case narrative: this spontaneous report originating from united states was received from a nurse manager via clinical sales educator (cse), referring to a female patient of unknown age.The patient¿s historical condition, current condition, concomitant medications and past drug reactions/allergies were not reported.This report concerns 1 patient(s) and 3 devices.Over the weekend ((b)(6) 2024-(b)(6) 2024), the patient underwent insertion with vacuum-induced hemorrhage control system (jada system) (lot and expiration date were not reported) via intravaginal route for bleeding.The clinical sales educator (cse) spoke with the nurse manager and was given additional information.The nurse manager said it was user error and not quality issue.The physician did not sweep the uterus prior to the insertion (device use error).All 3 devices were discarded.The third vacuum-induced hemorrhage control system (jada system) was inserted which worked and was left in place.The patient was transferred to the intensive care unit (icu) for a short time and then returned to labor and delivery.No additional information provided.No new adverse event (ae) (no adverse event) or product quality complaint (pqc) reported.The patient was sought medical attention.Therapy with vacuum-induced hemorrhage control system (jada system) was withdrawn.The outcome of event device use error was unknown.Upon internal review, the event of device use error was determined to be serious due to due required intervention (devices) and hospitalization.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): 4608 intensive care (patient requires admission to or extension of stay in an intensive care unit).Fda code: (health effects - health impact per annex f): 4607 hospitalization or prolonged hospitalization (hospitalization or prolonged hospitalization due to the health damage accompanying the use of device).

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.

• 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: 18779567
• MDR Text Key: 336235565
• Report Number: 3002806821-2024-00010
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2024

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?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/26/2024; 04/16/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female