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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 Problems Fever (1858); Hemorrhage/Bleeding (1888); Thrombosis/Thrombus (4440)
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
When the cervical seal was deflated and the jada system removed the patient passed large blood clots [thrombosis].Had an increased temperature/fever [pyrexia].Provider did not deflate the cervical seal after the suction was turned off.Reporter states the cervical seal was left inflated "overnight" even after the suction was turned off.[wrong technique in device usage process].Case narrative: this initial spontaneous report was received from a physician via company representative referring to a non-pregnant female patient of unknown age.The patient's historical conditions included pregnancy and had delivery.The patient's concomitant medications included oxytocin citrate (pitocin), the patient had prolonged rupture of the membrane and likely had misoprostol (cytotec).The patient¿s concurrent conditions included endometritis and hospitalization for the delivery.The patient¿s drug reactions/allergies were not reported.This report concerns 1 patient and 1 device.It was reported that patient had bleeding late into the middle of the night and on an unknown date at 10 pm, the patient underwent vacuum-induced hemorrhage control system (jada system) placement via vaginal route by an attending physician for post-partum hemorrhage (postpartum haemorrhage) and had the suction on.It was reported that the vacuum-induced hemorrhage control system (jada system) functioned properly.The vacuum-induced hemorrhage control system (jada system) stopped the bleeding, but the physician said to turn the suction off at 5 or 6am and to not deflate the balloon and that physician would come by in an hour to pull it.The reporter stated the cervical seal was left inflated "overnight" even after the suction was turned off (wrong technique in device usage process).When the cervical seal was deflated and the vacuum-induced hemorrhage control system (jada system) removed, the patient passed large blood clots (thrombosis), had an increased temperature (also reported as ¿fever¿) (pyrexia).It was reported that vacuum-induced hemorrhage control system (jada system) was not watertight and if it was pulled during the night and she bleeds then physician had to come in and fix it but logistically if she was bleeding around the vacuum-induced hemorrhage control system (jada system) the nurses could have done suction.The patient had sought medical attention.The patient received 2 units of blood ("also reported as patient required blood products during peripartum period") and was given antibiotics.It was reported that patient was now fine.The physician stated that the patient¿s pyrexia was nothing to do with vacuum-induced hemorrhage control system (jada system).No product quality complaint (pqc) was reported.No further information was provided at the time of reporting as physician only returned the phone call as he thought the patient had been readmitted to the hospital.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 available.The outcome of thrombosis and pyrexia was reported as recovered.The reporter considered pyrexia to be not related to vacuum-induced hemorrhage control system (jada system), and it was not provided for thrombosis.Upon internal review, the event of thrombosis was determined to be medically significant.Medical device reporting criteria: serious injury.(b)(4).
 
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
When the cervical seal was deflated and the jada system removed the patient passed large blood clots [vaginal haemorrhage] had an increased temperature/fever [pyrexia] provider did not deflate the cervical seal after the suction was turned off.Reporter states the cervical seal was left inflated "overnight" even after the suction was turned off.[wrong technique in device usage process] case narrative: this initial spontaneous report was received from a physician via company representative referring to a non-pregnant female patient of unknown age.The patient's historical conditions included pregnancy and had delivery.The patient's concomitant medications included oxytocin citrate (pitocin), the patient had prolonged rupture of the membrane and likely had misoprostol (cytotec).The patient¿s concurrent conditions included endometritis and hospitalization for the delivery.The patient¿s drug reactions/allergies were not reported.This report concerned 1 patient and 1 device.It was reported that patient had bleeding late into the middle of the night and on an unknown date at 10 pm, the patient underwent vacuum-induced hemorrhage control system (jada system) placement via vaginal route by an attending physician for post-partum hemorrhage (postpartum haemorrhage) and had the suction on.It was reported that the vacuum-induced hemorrhage control system (jada system) functioned properly.The vacuum-induced hemorrhage control system (jada system) stopped the bleeding, but the physician said to turn the suction off at 5 or 6am and to not deflate the balloon and that physician would come by in an hour to pull it.The reporter stated the cervical seal was left inflated "overnight" even after the suction was turned off (wrong technique in device usage process).When the cervical seal was deflated and the vacuum-induced hemorrhage control system (jada system) removed, the patient passed large blood clots (thrombosis), had an increased temperature (also reported as ¿fever¿) (pyrexia).It was reported that vacuum-induced hemorrhage control system (jada system) was not water-tight and if it was pulled during the night and she bleeds then physician had to come in and fix it but logistically if she was bleeding around the vacuum-induced hemorrhage control system (jada system) the nurses could have done suction.The patient had sought medical attention.The patient received 2 units of blood ("also reported as patient required blood products during peripartum period") and was given antibiotics.It was reported that patient was now fine.The physician stated that the patient¿s pyrexia was nothing to do with vacuum-induced hemorrhage control system (jada system).No product quality complaint (pqc) was reported.No further information was provided at the time of reporting as physician only returned the phone call as he thought the patient had been readmitted to the hospital.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 available.The outcome of thrombosis and pyrexia was reported as recovered.The reporter considered pyrexia to be not related to vacuum-induced hemorrhage control system (jada system), and causality was not provided for thrombosis.Upon internal review, the event of thrombosis was determined to be medically significant.Medical device reporting criteria: serious injury.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).This is an amended report.The event of thrombosis was updated to vaginal haemorrhage.
 
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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 Key15950343
MDR Text Key305181034
Report Number3002806821-2022-00018
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 12/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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
Type of Device Usage Initial
Patient Sequence Number1
Treatment
CYTOTEC (MISOPROSTOL),; CYTOTEC (MISOPROSTOL),; PITOCIN [OXYTOCIN CITRATE] (OXYTOCIN CITRATE),; PITOCIN [OXYTOCIN CITRATE] (OXYTOCIN CITRATE),
Patient Outcome(s) Other;
Patient SexFemale
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