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

It clotted off [device occlusion] user error /did not sweep [device use error] no new adverse event (ae) 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), 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 patient had first vacuum-induced hemorrhage control system (jada system) inserted and it clotted off and it was removed (device occlusion).The patient was transferred to the intensive care unit (icu) for a short time and then returned to labor and delivery.No new adverse event (ae) (no adverse event) or product quality complaint (pqc) reported.Therapy with vacuum-induced hemorrhage control system (jada system) was withdrawn.The outcome of event device use error and device occlusion was unknown.Upon internal review, the event of device use error and device occlusion was determined to be serious 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): 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): 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.

Event Description

It clotted off [device occlusion] user error /did not sweep [device use error] no new adverse event (ae) 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 patient had first vacuum-induced hemorrhage control system (jada system) inserted and it clotted off and it was removed (device occlusion).The patient was transferred to the intensive care unit (icu) for a short time and then returned to labor and delivery.No new adverse event (ae) (no adverse event) or product quality complaint (pqc) reported.Therapy with vacuum-induced hemorrhage control system (jada system) was withdrawn.The outcome of event device use error and device occlusion was unknown.Upon internal review, the event of device use error and device occlusion was determined to be serious 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): 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): 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.

Event Description

It clotted off [device occlusion].User error /did not sweep [device use error].No new adverse event (ae) 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 on (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 patient had first vacuum-induced hemorrhage control system (jada system) inserted and it clotted off and it was removed (device occlusion).The patient was transferred to the intensive care unit (icu) for a short time and then returned to labor and delivery.No new adverse event (ae) (no adverse event) reported.Therapy with vacuum-induced hemorrhage control system (jada system) was withdrawn.The outcome of event device use error and device occlusion was unknown.Upon internal review, the event of device use error and device occlusion was determined to be serious 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): 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): 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 and aer#: (b)(4) referred to device 3.This is an amendment report.Seriousness, regarding hospitalization and ¿or product quality complaint (pqc) reported' statements were removed from the narrative as product problem was checked as yes.For the events onset date was updated as february 2024 from 09-feb-2024.Linking cases statement was updated in narrative.Medical device reporting criteria: serious injury.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.

• 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: 18779569
• MDR Text Key: 336295425
• Report Number: 3002806821-2024-00009
• 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?: Yes
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female