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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 02/16/2023
Event Type  Injury  
Event Description
She still could not place/physician was unable to insert the jada [complication of device insertion] she did try using ring forceps [wrong technique in device usage process] the patient was not dilated to 3 centimeters, she was probably only at 1 centimeter when they tried to insert the jada [contraindicated device used].Case narrative: this spontaneous report was received from a nurse via clinical sales educator (cse) referring to a female patient of unknown age.The patient had singleton pregnancy and had a scheduled cesarean delivery.Gestational age at delivery was mentioned as term.Spinal anaesthesia was used during delivery.There was no invasive placenta.The patient had no previous history of abnormal postpartum uterine bleeding or hemorrhage.The patient's concurrent condition included obesity, hypertension (htn), asthma and lower uterine segment atony.Patient was gravida 5 and para 5.The patient also required 2 units of blood during the peripartum period.Maternal intensive care united (icu) was not required and patient was not diagnosed with endometritis.The patient was given oxytocin prior to use of vacuum-induced hemorrhage control system (jada system).This report concerns 1 patient and 1 device.On (b)(6) 2023, a resident physician attempted to place vacuum-induced hemorrhage control system (jada system) (route, lot# and expiration date were not reported) for uterine bleeding (uterine haemorrhage).She felt that it was floppy when trying to insert.She said it would be much easier if there was something that held the loop closed, like the plastic sleeve that covers the intrauterine pressure catheter (iupc) that could be removed once the device is inserted.She did try that using ring forceps to help but she still could not place (wrong technique in device usage process).She was trying to place because meds cannot be given due to contraindications.In addition, it was also stated that the patient was not dilated to 3 centimeters, she was probably only at 1 centimeter when they tried to insert the vacuum-induced hemorrhage control system (jada system) (contraindicated device used).The physician did state that she knew the patient was supposed to be dilated to 3 centimeters for vacuum-induced hemorrhage control system (jada system) use.It was also reported that the patient lost 2 liters of blood and the physician was unable to insert the vacuum-induced hemorrhage control system (jada system) (complication of device insertion), they ended up inserting a bakri uterine balloon.Reporter believed that vacuum-induced hemorrhage control system (jada system) came with a blue seal valve, kit, no irregular shape noticed when the packet was first opened, there was no damage noted to the carton or tray, shape of the loop was normal.No ultrasound was used at any point to evaluate during vacuum-induced hemorrhage control system (jada system) use.The device was stored in an office prior to use.No additional adverse event (ae) or product quality complaint (pqc) reported.Upon internal review, the event of "complication of device insertion and wrong technique in device usage process " were determined to be serious due to required intervention.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.
 
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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 Key16528264
MDR Text Key311219563
Report Number3002806821-2023-00019
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 Other
Type of Report Initial
Report Date 03/10/2023
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
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/13/2023
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
OXYTOCIN (OXYTOCIN).
Patient Outcome(s) Required Intervention;
Patient SexFemale
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