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

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

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)

Event Date 04/14/2023

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

Patient's bleeding was never controlled [device ineffective].Patient's systolic blood pressure went down to 49 [blood pressure systolic decreased].Case narrative: this initial spontaneous report originating from the united states, was received from a clinical educator referring to a non-pregnant female patient.The patient's concurrent conditions included hypertension, multigravida (reported as g9) and multiparous (reported as 3 live births).The patient's medical history included abnormal postpartum uterine bleeding or hemorrhage, uterine dilation and curettage (reported as 3 or 4 d and c's), abortion spontaneous and precipitous deliveries.Her concomitant medications were not reported.It was reported that on an unknown date in (b)(6) 2023, the patient had vaginal delivery at 38 weeks of gestation.The delivery was induced with high dose of oxytocin (pitocin) 42 (unit not reported).No epidural was given.Unspecified transfusions were given.The was no invasive placenta.The amount of blood loss prior to use of vacuum-induced hemorrhage control system (jada system) was 500 (unit not reported).This report concerns 1 patient and 1 device.On (b)(6) 2023, the patient underwent vacuum-induced hemorrhage control system (jada system) via intravaginal route (lot# and expiry date were not reported) placement, by attending physician for postpartum hemorrhage.The device came with blue seal valve.The cause of the postpartum hemorrhage was suspected to be in disseminated intravascular coagulation (dic).The clinical educator reported that 120 cc was used for the seal per the nurses.But patient's bleeding was never controlled (device ineffective, onset date: (b)(6) 2023).They were unsure if it was a vacuum-induced hemorrhage control system (jada system) (refer oars # (b)(4)) quality issue.As they were unsure if first device was functioning properly, so another vacuum-induced hemorrhage control system (jada system) was used but bleeding continued.The patient's uterus was firm.The patient sought medical attention.The patient was in dic and was intubated taken to surgery and had hysterectomy.The patient was admitted into the intensive care unit (icu) for treatment and was extubated the next day.The patient required blood transfusions due to 5 liter blood loss after use of the device (reported as collected in the vacuum-induced hemorrhage control system (jada system) canister).On an unknown date in (b)(6) 2023, the patient's systolic blood pressure went down to 49 (unit not reported) (blood pressure systolic decreased).It was also reported that the device was removed and then reinserted, and it wasn't operator's first time using the device.The vacuum-induced hemorrhage control system (jada system) was not available for evaluation as it was discarded.The outcome of the event blood pressure systolic decreased was unknown.Causality of the events blood pressure systolic decreased with the suspect therapy was unknown.Upon internal review, the event of device ineffective was determined to be serious as it required intervention and hospitalization.The reporter considered the event blood pressure systolic decreased to be medically significant.This is one of the 2 reports received from the same source, referring to the same patient.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): 4624 surgical intervention (one or more surgical procedures was required, or an existing procedure changed).Fda code: (health effects - health impact per annex f): 4643 blood transfusion (patient required an infusion of whole blood or a blood component directly into the bloodstream).

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

Patient's bleeding was never controlled [device ineffective].Patient's systolic blood pressure went down to 49 [blood pressure systolic decreased].Case narrative: this initial spontaneous report originating from the united states, was received from a clinical educator referring to a non-pregnant female patient.The patient's concurrent conditions included hypertension, multigravida (reported as g9) and multiparous (reported as 3 live births).The patient's medical history included abnormal postpartum uterine bleeding or hemorrhage, uterine dilation and curettage (reported as 3 or 4 d and c's), abortion spontaneous and precipitous deliveries.Her concomitant medications were not reported.It was reported that on an unknown date in april 2023, the patient had vaginal delivery at 38 weeks of gestation.The delivery was induced with high dose of oxytocin (pitocin) 42 (unit not reported).No epidural was given.Unspecified transfusions were given.The was no invasive placenta.The amount of blood loss prior to use of vacuum-induced hemorrhage control system (jada system) was 500 (unit not reported).This report concerns 1 patient and 1 device.On 14-apr-2023, the patient underwent vacuum-induced hemorrhage control system (jada system) via intravaginal route (lot# and expiry date were not reported) placement, by attending physician for postpartum hemorrhage.The device came with blue seal valve.The cause of the postpartum hemorrhage was suspected to be in disseminated intravascular coagulation (dic).The clinical educator reported that 120 cc was used for the seal per the nurses.But patient's bleeding was never controlled (device ineffective, onset date: 14-apr-2023).They were unsure if it was a vacuum-induced hemorrhage control system (jada system) (refer oars # (b)(4)) quality issue.As they were unsure if first device was functioning properly, so another vacuum-induced hemorrhage control system (jada system) was used but bleeding continued.The patient's uterus was firm.The patient sought medical attention.The patient was in dic and was intubated taken to surgery and had hysterectomy.The patient was admitted into the intensive care unit (icu) for treatment and was extubated the next day.The patient required blood transfusions due to 5 liter blood loss after use of the device (reported as collected in the vacuum-induced hemorrhage control system (jada system) canister).On an unknown date in (b)(6) 2023, the patient's systolic blood pressure went down to 49 (unit not reported) (blood pressure systolic decreased).It was also reported that the device was not removed and then reinserted, and it wasn't operator's first time using the device.The vacuum-induced hemorrhage control system (jada system) was not available for evaluation as it was discarded.The outcome of the event blood pressure systolic decreased was unknown.Causality of the events blood pressure systolic decreased with the suspect therapy was unknown.Upon internal review, the event of device ineffective was determined to be serious as it required intervention and hospitalization.The reporter considered the event blood pressure systolic decreased to be medically significant.This is one of the 2 reports received from the same source, referring to the same patient.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): 4624 surgical intervention (one or more surgical procedures was required, or an existing procedure changed).Fda code: (health effects - health impact per annex f): 4643 blood transfusion (patient required an infusion of whole blood or a blood component directly into the bloodstream.) follow up information was received from the clinical educator on 02-may-2023.The clinical educator informed that the vacuum-induced hemorrhage control system (jada system) was not malfunctioning or defective.The provider said that it was initiated too late, and the patient had uncontrolled bleeding due to dic (previously reported as suspected).

• 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: 16890508
• MDR Text Key: 314805753
• Report Number: 3002806821-2023-00048
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• PMA/PMN Number: 510K K201199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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; Other
• Patient Sex: Female