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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORGANON & CO. JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM
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ORGANON & CO. JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 06/14/2023
Event Type  Injury  
Event Description
Provider reported the patient continued to have blood leaking around the cervical seal [device ineffective].Case narrative: this initial spontaneous report originating from the united states was received from a physician via clinical account specialist (cas), referring to a female patient of unknown age.The patient's medical history included singleton pregnancy and vaginal delivery.Her current conditions included gravida 2 and para 2 (also reported as "2nd baby").She had uterine atony with a "boggy lower uterine segment" and was treated with carboprost trometamol (hemabate) and methylergometrine maleate (methergine) prior to vacuum-induced hemorrhage control system (jada system) use (also reported as treatment; discrepancy).Her past drugs and allergies were not reported.This report concerned 1 patient and 1 device.On (b)(6) 2023, the patient was inserted with vacuum-induced hemorrhage control system (jada system) via vaginal route (lot #, serial # and expiry date were not reported) by the physician for vaginal bleeding postpartum (postpartum haemorrhage).The physician reported that she inflated the seal to 120 and tried to push the device up to the uterine fundus but she thought that she pushed it through the cervix.The patient continued to have blood leaking around the cervical seal (device ineffective, onset date: (b)(6) 2023).Therefore, it was removed on the same day and a bakri balloon was placed which controlled the bleeding.On an unknown date in (b)(6) 2023, the patient was hospitalized due to the event.The patient lost a total of 1700 ml of blood.Reportedly, it was the first use of the vacuum-induced hemorrhage control system (jada system) by the physician and the cas stated that the physician needed more training.It was also reported that more than 1 device was not used.The device was not removed and reinserted for any reason.An ultrasound was not used at any point to evaluate during vacuum-induced hemorrhage control system (jada system) use.The suspected cause of the postpartum haemorrhage was uterine atony.No additional adverse event (ae)/product quality complaint (pqc) was identified.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.Upon internal review, the event of device ineffective was considered to be serious as it 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): 4641 unexpected medical intervention (patient required an unforeseen medical intervention, excluding surgery, which was not on the original treatment plan).
 
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.
 
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 reported the patient continued to have blood leaking around the cervical seal [device ineffective] case narrative: this initial spontaneous report originating from the united states was received from a physician via clinical account specialist (cas), referring to a female patient of unknown age.The patient's medical history included singleton pregnancy and vaginal delivery.Her current conditions included gravida 2 and para 2 (also reported as "2nd baby").She had uterine atony with a "boggy lower uterine segment" and was treated with carboprost trometamol (hemabate) and methylergometrine maleate (methergine) prior to vacuum-induced hemorrhage control system (jada system) use (also reported as treatment; discrepancy).Her past drugs and allergies were not reported.This report concerned 1 patient and 1 device.On (b)(6) 2023, the patient was inserted with vacuum-induced hemorrhage control system (jada system) via vaginal route (lot #, serial # and expiry date were not reported) by the physician for vaginal bleeding postpartum (postpartum haemorrhage).The physician reported that she inflated the seal to 120 and tried to push the device up to the uterine fundus but she thought that she pushed it through the cervix.The patient continued to have blood leaking around the cervical seal (device ineffective, onset date: (b)(6) 2023).Therefore, it was removed on the same day and a bakri balloon was placed which controlled the bleeding.On an unknown date in (b)(6) 2023, the patient was hospitalized due to the event.The patient lost a total of 1700 ml of blood.Reportedly, it was the first use of the vacuum-induced hemorrhage control system (jada system) by the physician and the cas stated that the physician needed more training.It was also reported that more than 1 device was not used.The device was not removed and reinserted for any reason.An ultrasound was not used at any point to evaluate during vacuum-induced hemorrhage control system (jada system) use.The suspected cause of the postpartum haemorrhage was uterine atony.No additional adverse event (ae)/product quality complaint (pqc) was identified.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.Upon internal review, the event of device ineffective was considered to be serious as it 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): 4641 unexpected medical intervention (patient required an unforeseen medical intervention, excluding surgery, which was not on the original treatment plan).Follow up information was received from the physician on (b)(6) 2023.The patient's concomitant medications included oxytocin (pitocin).The physician reported that the fundus of the uterus was super clamped down, and they could not get it up in there.The patient was bleeding from her lower uterine segment, the very lowest part.She had a very large baby, a prolonged second stage and the cervix had been dilated for a really long time.But the fundus responded to oxytocin (pitocin) and other uterotonics really well.The physician stated that it was not the device but the patient¿s anatomy, and that they should have started with the bakri balloon.
 
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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 Key17161409
MDR Text Key317446221
Report Number3002806821-2023-00072
Device Sequence Number1
Product Code OQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
510K K201199
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/22/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2023
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
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 Number1
Treatment
HEMABATE (CARBOPROST TROMETAMOL),; HEMABATE (CARBOPROST TROMETAMOL),; METHERGINE (METHYLERGOMETRINE MALEATE),; METHERGINE (METHYLERGOMETRINE MALEATE),; PITOCIN [OXYTOCIN] (OXYTOCIN),
Patient Outcome(s) Required Intervention; Hospitalization;
Patient SexFemale
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