MAUDE Adverse Event Report: ORGANON LLC JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM

Model Number	JADA-1001
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The seal had ruptured and the jada system expelled [device expulsion], and realized the seal had ruptured and the jada system expelled [device breakage], then moved the patient from one bed to another and realized the seal had ruptured [device use issue], no additional ae/pqc reported [no adverse event].Case narrative: this spontaneous report originating from united states was received from a registered nurse referring to a female patient of unknown age via clinical account specialist (cas).The patient¿s medical history, current conditions, concomitant medications and past drug reactions/allergies were not reported.This report concerns 1 patient(s) and 1 device(s).On an unknown date, the patient was placed with vacuum-induced hemorrhage control system (jada system) via intravaginal route (defaulted) (lot#, serial # and expiration date were not reported) for an unknown indication.After inserting the vacuum-induced hemorrhage control system (jada system), the nurse injected a total of 120 milliliters of sterile fluid into the cervical seal.Then the patient was moved from one bed to another (device use issue) and realized the seal had ruptured (device breakage) and the vacuum-induced hemorrhage control system (jada system) had been expelled (device expulsion).The nurse did place another vacuum-induced hemorrhage control system (jada system), that worked as expected.The patient did not seem bothered or surprised by this adverse event and was just grateful they identified what happened.The complaint sample was disposed of and was not available for product retrieval and it was unknown if any product images were obtained.No additional adverse event (ae)/ product quality complaint (pqc) reported (no adverse event).The outcome of event device expulsion was unknown.Upon internal review, the event device expulsion was considered to be medically significant.Medical device reporting criteria: malfunction.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.
Additional Manufacturer Narrative
Lot number has not been identified for this complaint.(currently identified as unknown).Investigation of the event by the manufacturing site is ongoing.
Event or Problem Description
The seal had ruptured and the jada system expelled [device expulsion] and realized the seal had ruptured and the jada system expelled [device breakage] then moved the patient from one bed to another and realized the seal had ruptured [device use issue], no additional ae/pqc reported [no adverse event].Case narrative: this spontaneous report originating from united states was received from a registered nurse referring to a female patient of unknown age via clinical account specialist (cas).The patient¿s medical history, current conditions, concomitant medications and past drug reactions/allergies were not reported.This report concerns 1 patient(s) and 1 device(s).On an unknown date, the patient was placed with vacuum-induced hemorrhage control system (jada system) 1001 via intravaginal route (defaulted) (lot#, serial # and expiration date were not reported) for an unknown indication.After inserting the vacuum-induced hemorrhage control system (jada system), the nurse injected a total of 120 milliliters of sterile fluid into the cervical seal.Then the patient was moved from one bed to another (device use issue) and realized the seal had ruptured (device breakage) and the vacuum-induced hemorrhage control system (jada system) had been expelled (device expulsion).The nurse did place another vacuum-induced hemorrhage control system (jada system), that worked as expected.The patient did not seem bothered or surprised by this adverse event and was just grateful they identified what happened.The complaint sample was disposed of and was not available for product retrieval and it was unknown if any product images were obtained.No additional adverse event (ae)/ product quality complaint (pqc) reported (no adverse event).The outcome of event device expulsion was unknown.Upon internal review, the event device expulsion was considered to be medically significant.Medical device reporting criteria: malfunction.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.Follow-up information has been received from quality investigation team on 29-jan-2025.This is a final report.No complaint sample or device lot number are available for evaluation; therefore, an unknown investigation was performed.The device is assembled per specifications where in-process and final inspections are conducted by trained personnel.No outcome from the investigation could be determined since no complaint sample or lot identification has been provided.If the complaint sample or lot number become available, this complaint will be re-opened, and additional investigation may be performed.Case comments: the complaint does not have the level of detail necessary to determine if there were other objects that could have ruptured the jada cervical seal therefore, it should conservatively be classified as a malfunction now until additional clarity is provided around the circumstances of the rupture.At which point it may not be classified as a malfunction.
Additional Manufacturer Narrative
No complaint sample or device lot number are available for evaluation, therefore an unknown investigation was performed.The device is assembled per specifications where in-process and final inspections are conducted by trained personnel.No outcome from the investigation could be determined since no complaint sample or lot identification has been provided.If the complaint sample or lot number become available, this complaint will be re-opened and additional investigation may be performed.
Event or Problem Description
The seal had ruptured and the jada system expelled [device expulsion] and realized the seal had ruptured and the jada system expelled [device breakage] then moved the patient from one bed to another and realized the seal had ruptured [device use issue], no additional ae/pqc reported [no adverse event].Case narrative: this spontaneous report originating from united states was received from a registered nurse referring to a female patient of unknown age via clinical account specialist (cas).The patient¿s medical history, current conditions, concomitant medications and past drug reactions/allergies were not reported.This report concerns 1 patient(s) and 1 device(s).On an unknown date, the patient was placed with vacuum-induced hemorrhage control system (jada system) 1001 via intravaginal route (defaulted) (lot#, serial # and expiration date were not reported) for an unknown indication.After inserting the vacuum-induced hemorrhage control system (jada system), the nurse injected a total of 120 milliliters of sterile fluid into the cervical seal.Then the patient was moved from one bed to another (device use issue) and realized the seal had ruptured (device breakage) and the vacuum-induced hemorrhage control system (jada system) had been expelled (device expulsion).The nurse did place another vacuum-induced hemorrhage control system (jada system), that worked as expected.The patient did not seem bothered or surprised by this adverse event and was just grateful they identified what happened.The complaint sample was disposed of and was not available for product retrieval and it was unknown if any product images were obtained.No additional adverse event (ae)/ product quality complaint (pqc) reported (no adverse event).The outcome of event device expulsion was unknown.Upon internal review, the event device expulsion was considered to be medically significant.Medical device reporting criteria: malfunction.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.Follow-up information has been received from quality investigation team on 29-jan-2025.This is a final report.No complaint sample or device lot number are available for evaluation; therefore, an unknown investigation was performed.The device is assembled per specifications where in-process and final inspections are conducted by trained personnel.No outcome from the investigation could be determined since no complaint sample or lot identification has been provided.If the complaint sample or lot number become available, this complaint will be re-opened, and additional investigation may be performed.This is an amended report: updated malfunction type as cirm.Case comments: the complaint does not have the level of detail necessary to determine if there were other objects that could have ruptured the jada cervical seal therefore, it should conservatively be classified as a malfunction now until additional clarity is provided around the circumstances of the rupture.At which point it may not be classified as a malfunction.
Additional Manufacturer Narrative
No complaint sample or device lot number are available for evaluation, therefore an unknown investigation was performed.The device is assembled per specifications where in-process and final inspections are conducted by trained personnel.No outcome from the investigation could be determined since no complaint sample or lot identification has been provided.If the complaint sample or lot number become available, this complaint will be re-opened and additional investigation may be performed.

• Brand Name: JADA SYSTEM
• Common Device Name: INTRAUTERINE VACUUM CONTRACTION SYSTEM
• Manufacturer (Section D): ORGANON LLC; 30 hudson street; jersey city NJ 07302
• Manufacturer (Section G): ORGANON LLC; 30 hudson street; jersey city NJ 07302
• Manufacturer Contact: tara brolly ; 30 hudson street; jersey city, NJ 07302
• MDR Report Key: 20830930
• Report Number: 3002806821-2024-00101
• Device Sequence Number: 8864961
• Product Code: OQY
• UDI-Device Identifier: 00850017882003
• UDI-Public: 00850017882003
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2025

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
• Operator of Device: Health Professional
• Device Model Number: JADA-1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 02/03/2025; 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female