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

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/01/2023

Event Type  Injury  

Event Description

Provider inserted the jada system according to the instructions for use, and within 3 minutes, bleeding was controlled.The jada system remained in place for "a few hours", and then blood began to fill the canister/ another bleeding episode [device effect incomplete].The jada system remained in place for "a few hours", and then blood began to fill the canister.Patient was noted to have had a uterine rupture requiring surgical intervention.[contraindicated device used].Case narrative: this spontaneous report originating from the united states was received from a nurse educator via clinical sales educator (cse), referring to a non-pregnant female patient of an unknown age.The patient's medical history included singleton pregnancy and vaginal delivery.Her current condition included uterine rupture, and her concomitant medication included oxytocin.Her past drug reactions/allergies were not reported.This report concerns 1 patient and 1 device.On an unknown date in (b)(6) 2023 (reported as "last week"), the patient was placed with vacuum-induced hemorrhage control system (jada system) via vaginal route for postpartum haemorrhage by an unspecified provider, and within 3 minutes, the bleeding was controlled.The device remained in place for a few hours, however, then blood began to fill the canister/another bleeding episode (device effect incomplete).Patient was noted to have had a uterine rupture requiring surgical intervention (contraindicated device used).On the same day, the device was removed.The suspected cause of postpartum haemorrhage was uterine rupture.It was unknown if the patient required hospitalization post-surgery.At the time of reporting, the patient had recovered from the uterine rupture.Reportedly, more than one device was not used.The device was not removed and then reinserted for any reason.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.For vacuum-induced hemorrhage control system (jada system), lot number and serial number were not provided.Upon internal review, the event of device effect incomplete was considered to be serious due to required intervention.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).

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

Provider inserted the jada system according to the instructions for use, and within 3 minutes, bleeding was controlled.The jada system remained in place for "a few hours", and then blood began to fill the canister/ another bleeding episode [device effect incomplete] the jada system remained in place for "a few hours", and then blood began to fill the canister.Patient was noted to have had a uterine rupture requiring surgical intervention.[contraindicated device used] case narrative: this spontaneous report originating from the united states was received from a nurse educator via clinical sales educator (cse), referring to a non-pregnant female patient of an unknown age.The patient's medical history included singleton pregnancy and vaginal delivery.Her current condition included uterine rupture, and her concomitant medication included oxytocin.Her past drug reactions/allergies were not reported.This report concerns 1 patient and 1 device.On an unknown date in (b)(6) 2023 (reported as "last week"), the patient was placed with vacuum-induced hemorrhage control system (jada system) via vaginal route for postpartum haemorrhage by an unspecified provider, and within 3 minutes, the bleeding was controlled.The device remained in place for a few hours, however, then blood began to fill the canister/another bleeding episode (device effect incomplete).Patient was noted to have had a uterine rupture requiring surgical intervention (contraindicated device used).On the same day, the device was removed.The suspected cause of postpartum haemorrhage was uterine rupture.It was unknown if the patient required hospitalization post-surgery.At the time of reporting, the patient had recovered from the uterine rupture.Reportedly, more than one device was not used.The device was not removed and then reinserted for any reason.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.For vacuum-induced hemorrhage control system (jada system), lot number and serial number were not provided.Upon internal review, the event of device effect incomplete was considered to be serious due to required intervention.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).Follow up information was received from unspecified reporter on 28-aug-2023.The vacuum-induced hemorrhage control system (jada system) came with green carton.The patient had gravida 3 and para 2.The patient had given a live birth in the past and had no history of abnormal post-partum uterine bleeding or hemorrhage.For current pregnancy the gestational age at delivery was 36 weeks and 5 days.It was induced delivery and agent oxytocin (pitocin) was used during pre-delivery.There was no invasive placenta.The following interventions were used prior to vacuum-induced hemorrhage control system (jada system) use: fundal massage, methylergometrine maleate (methergine) (reported as "metherine"), carboprost trometamol (hemabate), misoprostol (cytotec) and tranexamic acid (txa).No lower uterine segment atony was involved.The attending physician was the operator of the vacuum-induced hemorrhage control system (jada system) who received the training on 06-feb-2023 for how to use vacuum-induced hemorrhage control system (jada system).No ultrasound was used at any point to evaluate during vacuum-induced hemorrhage control system (jada system).The abnormal postpartum uterine bleeding or hemorrhage was initially controlled by vacuum-induced hemorrhage control system (jada system) and uterine repair was performed in operating room and controlled emergency room (er).1700 milliliter blood was collected in the vacuum-induced hemorrhage control system (jada system) canister.No disseminated intravascular coagulation (dic) was diagnosed.Six units of packed red blood cells and 2 units blood plasma (fresh frozen plasma) was required during peripartum period.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).

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: 17622477
• MDR Text Key: 321923734
• Report Number: 3002806821-2023-00100
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/30/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/30/2023
• 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
• Treatment: CYTOTEC (MISOPROSTOL),; FRESH FROZEN PLASMA (BLOOD PLASMA),; HEMABATE (CARBOPROST TROMETAMOL),; METHERGINE (METHYLERGOMETRINE MALEATE),; OXYTOCIN (OXYTOCIN),; PITOCIN [OXYTOCIN] (OXYTOCIN),; RED BLOOD CELLS (RED BLOOD CELLS),; TRANEXAMIC ACID (TRANEXAMIC ACID),
• Patient Outcome(s): Required Intervention
• Patient Sex: Female