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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
Lot Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Micturition Urgency (1871); Urinary Retention (2119)
Event Date 12/13/2023
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
The patient continued to report the urge to void and as though her bladder was full.Urinary retention.Urge to void : micturition urgency.Case narrative: this spontaneous report was received from a nurse via clinical sales educator, referring to a female patient of unknown age.The patient's historical condition included c-section (post c/s patient).Her concurrent condition, past drugs/allergies and concomitant medications were not reported.This report concerns 1 patient and 1 device.On (b)(6) 2023, the patient was placed with vacuum-induced hemorrhage control system (jada system) via intrauterine route (lot/ batch#, expiry date was not reported) for postpartum hemorrhage.The patient had jada in place, and it effectively stopped her postpartum hemorrhage (pph), however, on (b)(6) 2023, her bladder was not able to drain even with a foley in place.They initially had the cervical balloon inflated with 120 cc sterile fluid and thought her bladder might not be able to effectively drain due to pressure on the urethra from the jada balloon.During troubleshooting, the provider removed 20cc of fluid to equal 100cc in the balloon with no urine drainage.Next, the nurse removed the foley catheter and placed a new foley still no drainage.The provider then removed another 40cc of fluid from the jada cervical balloon (total 60cc in balloon) and was able to drain 53cc from the bladder.The patient continued to report the urge to void and as though her bladder was full (urinary retention) (micturition urgency).Since jada was effective for this patient's pph and had received adequate treatment time, they removed jada.Immediately after removing jada, nearly 3l was drained from the bladder.The facility was inquiring as to if this has happened before.The outcome of the events was recovered.The causality assessment was not provided.Upon internal review, the event of urinary retention was determined to be medically significant.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.
 
Event Description
The patient continued to report the urge to void and as though her bladder was full.[urinary retention] urge to void [micturition urgency] case narrative: this spontaneous report was received from a nurse via clinical sales educator, referring to a female patient of unknown age.The patient's historical condition included c-section (post c/s patient).Her concurrent condition, past drugs/allergies and concomitant medications were not reported.This report concerns 1 patient and 1 device.On 13-dec-2023, the patient was placed with vacuum-induced hemorrhage control system (jada system) via intrauterine route (lot/ batch#, expiry date was not reported) for postpartum hemorrhage.The patient had jada in place, and it effectively stopped her postpartum hemorrhage (pph), however, on 13-dec-2023, her bladder was not able to drain even with a foley in place.They initially had the cervical balloon inflated with 120 cc sterile fluid and thought her bladder might not be able to effectively drain due to pressure on the urethra from the jada balloon.During troubleshooting, the provider removed 20cc of fluid to equal 100cc in the balloon with no urine drainage.Next, the nurse removed the foley catheter and placed a new foley still no drainage.The provider then removed another 40cc of fluid from the jada cervical balloon (total 60cc in balloon) and was able to drain 53cc from the bladder.The patient continued to report the urge to void and as though her bladder was full (urinary retention) (micturition urgency).The patient sought medical attention.The patient did not have any urinary output while vacuum-induced hemorrhage control system (jada system) was in place and was inquiring if this has happened with other patients utilizing vacuum-induced hemorrhage control system (jada system).Since jada was effective for this patient's pph and had received adequate treatment time, they removed jada.Immediately after removing jada, nearly 3l was drained from the bladder.The facility was inquiring as to if this has happened before.The outcome of the events was recovered.The causality assessment was not provided.Upon internal review, the event of urinary retention was determined to be medically significant.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.Follow up information was received from the nurse on 19-dec-2023.The reporter stated that device worked just fine and did not document lot numbers.At the time of report, medical records for this event were not readily available.They could not remember the cause of post-partum hemorrhage.On an unknown date, the patient was admitted to the intensive care unit (icu) for elevated potassium and low hemoglobin.The patient returned to post-partum unit prior to discharge home.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.
 
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 Key18382604
MDR Text Key331183891
Report Number3002806821-2023-00138
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 Nurse
Type of Report Initial,Followup
Report Date 01/18/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
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
Patient Outcome(s) Other;
Patient SexFemale
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