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 Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Insufficient Information (4580)

Event Date 02/01/2024

Event Type  Injury  

Event Description

Used 2 or 3 jadas over the weekend because she thought they were not working correctly because the patient continued to bleed [device ineffective].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 2 to 3 devices.Over the weekend ( (b)(6) 2024), the patient underwent insertion with vacuum-induced hemorrhage control system (jada system) (lot #, serial # and expiration date were not reported) via intravaginal route for bleeding.The clinical sales educator (cse) reporting an ae and possible pqc for the vacuum-induced hemorrhage control system (jada system) on behalf a nurse manager that was informed of the incident by the physician.The nurse manager reported the physician that 2 or 3 jadas were used over the weekend ( (b)(6) 2024) because she thought they were not working correctly as the patient continued to bleed (device ineffective).The patient was sought medical attention and required hospitalization.Therapy with vacuum-induced hemorrhage control system (jada system) was withdrawn.The outcome of event device ineffective was unknown.Upon internal review, the event of device ineffective was determined to be serious due to 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): 4607 hospitalization or prolonged hospitalization (hospitalization or prolonged hospitalization due to the health damage accompanying the use of device) 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).

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

Used 2 or 3 jadas over the weekend because she thought they were not working correctly because the patient continued to bleed/ blood didn't reach the canister [device ineffective] user error /did not sweep [device use error] hypotensive [hypotension] 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 2 to 3 devices.Over the weekend (09-feb-2024-11-feb-2024), the patient underwent insertion with vacuum-induced hemorrhage control system (jada system) (lot #, serial # and expiration date were not reported) via intravaginal route for bleeding.The clinical sales educator (cse) reporting an ae and possible pqc for the vacuum-induced hemorrhage control system (jada system) on behalf a nurse manager that was informed of the incident by the physician.The nurse manager reported the physician that 2 or 3 jadas were used over the weekend (09-feb-2024) because she thought they were not working correctly as the patient continued to bleed (device ineffective).The patient was sought medical attention and required hospitalization.Therapy with vacuum-induced hemorrhage control system (jada system) was withdrawn.The outcome of event device ineffective was unknown.Upon internal review, the event of device ineffective was determined to be serious due to 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): 4607 hospitalization or prolonged hospitalization (hospitalization or prolonged hospitalization due to the health damage accompanying the use of device) 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).Follow-up information has been received from nurse manager via clinical sales educator (cse) on 15-feb-2024.The clinical sales educator (cse) spoked 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.Another vacuum-induced hemorrhage control system (jada system) was inserted, and the blood did not reach the canister, so the provider removed it due to patient was hypotensive (hypotension).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.The patient was sought medical attention.The outcome of the event device use error was unknown.Upon internal review, the event of device ineffective and device use error was determined to be serious due to required intervention (devices) and hospitalization and event hypotension considered to be serious due to hospitalization.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.) 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.Local comments: this report no longer meets criteria for submission.

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

Used 2 or 3 jadas over the weekend because she thought they were not working correctly because the patient continued to bleed/ blood didn't reach the canister [device ineffective].User error /did not sweep [device use error].Hypotensive [hypotension].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 2 to 3 devices.Over the weekend on (b)(6) 2024), the patient underwent insertion with vacuum-induced hemorrhage control system (jada system) (lot#, serial# and expiration date were not reported) via intravaginal route for bleeding.The clinical sales educator (cse) reporting an ae and possible pqc for the vacuum-induced hemorrhage control system (jada system) on behalf a nurse manager that was informed of the incident by the physician.The nurse manager reported the physician that 2 or 3 jadas were used over the weekend on (b)(6) 2024) because she thought they were not working correctly as the patient continued to bleed (device ineffective).The patient was sought medical attention and required hospitalization.Therapy with vacuum-induced hemorrhage control system (jada system) was withdrawn.The outcome of event device ineffective was unknown.Upon internal review, the event of device ineffective was determined to be serious due to 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): 4607 hospitalization or prolonged hospitalization (hospitalization or prolonged hospitalization due to the health damage accompanying the use of device) 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).Follow-up information has been received from nurse manager via clinical sales educator (cse) on 15-feb-2024.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.Another vacuum-induced hemorrhage control system (jada system) was inserted, and the blood did not reach the canister, so the provider removed it due to patient was hypotensive (hypotension).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.The patient was sought medical attention.The outcome of the event device use error was unknown.Upon internal review, the event of device ineffective and device use error was determined to be serious due to required intervention (devices) and hospitalization and event hypotension considered to be serious due to hospitalization.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.) 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.As per internal review, it was identified that previous report was sent in error as "downgrade" which is incorrect as the case has not been downgraded.Please disregard the downgrade report previously shared.

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

Used 2 or 3 jadas over the weekend because she thought they were not working correctly because the patient continued to bleed/ blood didn't reach the canister.[device ineffective] user error /did not sweep [device use error] hypotensive [hypotension] 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 2 to 3 devices.Over the weekend (b)(6) 2024), the patient underwent insertion with vacuum-induced hemorrhage control system (jada system) (lot #, serial # and expiration date were not reported) via intravaginal route for bleeding.The clinical sales educator (cse) reporting an ae and possible pqc for the vacuum-induced hemorrhage control system (jada system) on behalf a nurse manager that was informed of the incident by the physician.The reporter stated that the provider used 2 or 3 jadas over the weekend of (b)(6) 2024 (onset date approximated to (b)(6) 2024) because she thought they were not working correctly as the patient continued to bleed (device ineffective).The patient sought medical attention and required hospitalization.Therapy with vacuum-induced hemorrhage control system (jada system) was withdrawn.The outcome of event device ineffective was unknown.The event of device ineffective required 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): 4607 hospitalization or prolonged hospitalization (hospitalization or prolonged hospitalization due to the health damage accompanying the use of device).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).Follow-up information has been received from nurse manager via clinical sales educator (cse) on 15-feb-2024.The clinical sales educator (cse) spoked 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.Another vacuum-induced hemorrhage control system (jada system) was inserted, and the blood did not reach the canister, so the provider removed it due to patient was hypotensive (hypotension).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.The patient was sought medical attention.The outcome of the event device use error was unknown.Upon internal review, the event of device ineffective and device use error was determined to be serious due to required intervention (devices).The events hypotension and device use error required hospitalization.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.) 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.As per internal review, it was identified that previous report was sent in error as "downgrade" which is incorrect as the case has not been downgraded.Please disregard the downgrade report previously shared.This is an amendment report correspondence contact checkbox was updated for primary reporter (nurse).Onset date for events was updated from (b)(6) 2024 to (b)(6) 2024.Hospitalization date was updated as (b)(6) 2024.Narrative was reframed to, "the reporter stated that the provider used 2 to 3 jadas over the weekend of (b)(6) 2024 (onset date approximated to (b)(6) 2024)".Narrative statement was updated from ¿the patient was sought¿ to ¿the patient sought medical attention¿ and change the seriousness statement for hospitalization.

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: 18721817
• MDR Text Key: 335707268
• Report Number: 3002806821-2024-00007
• 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,Followup
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• 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
• 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): Hospitalization; Required Intervention
• Patient Sex: Female