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

Model Number	JADA-1001
Medical Device Problem Codes	Component Incompatible (1108); Defective Device (2588); Component or Accessory Incompatibility (2897); Compatibility Problem (2960)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
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
Couldn't get the air out of the cervical seal [device defective].No additional ae reported, no pqc reported.[no adverse event].Case narrative: this spontaneous report originating from 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, past drugs or allergies, and concomitant medications were not reported.This report concerns 1 patient(s) and 1 device(s).Approximately in february 2024 (reported as sometime last week), the patient underwent insertion with vacuum-induced hemorrhage control system (jada system) (lot # and expiration date were not reported) via vaginal route for an unknown indication.The clinical account specialist (cas) reporting on behalf of the physician.Approximately in february 2024 (reported as sometime last week), the clinical account specialist (cas) reported that the physician put the luer-lock syringe in to deflate the vacuum-induced hemorrhage control system (jada system) and could not get the air out of the cervical seal (device defective).The physician obtained a second vacuum-induced hemorrhage control system (jada system) to use, and it worked just fine.The physician told staff to set the defective vacuum-induced hemorrhage control system (jada system) aside, but they did not.The clinical account specialist (cas) did not have any patient or product information to report and had no further details to provide.The physician only wanted to be contacted by email.The physician was requesting a replacement.No other adverse event (ae)/product quality complaint (pqc) reported (no adverse event).Vacuum-induced hemorrhage control system (jada system) was not broken (i.E., the plastic break apart).It was difficult to connect/lost connection during preparation.More than one vacuum-induced hemorrhage control system (jada system) device was used as the first one did not work.The operator of the device was attending physician.Therapy with vacuum-induced hemorrhage control system (jada system) was withdrawn.The outcome of events was unknown.Upon internal review, the event device defective was considered 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: malfunction.
Event or Problem Description
Couldn't get the air out of the cervical seal [device defective], no additional ae reported, no pqc reported.[no adverse event].Case narrative: this spontaneous report originating from 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, past drugs or allergies, and concomitant medications were not reported.This report concerns 1 patient(s) and 1 device(s).Approximately in (b)(6) 2024 (reported as sometime last week), the patient underwent insertion with vacuum-induced hemorrhage control system (jada system) (lot # and expiration date were not reported) via vaginal route for an unknown indication.Approximately in (b)(6) 2024 (reported as sometime last week), the physician put the luer-lock syringe in to deflate the vacuum-induced hemorrhage control system (jada system) and could not get the air out of the cervical seal (device defective).The physician obtained a second vacuum-induced hemorrhage control system (jada system) to use, and it worked just fine.The physician told staff to set the defective vacuum-induced hemorrhage control system (jada system) aside, but they did not.The clinical account specialist (cas) did not have any patient or product information to report and had no further details to provide.The physician only wanted to be contacted by email.The physician was requesting a replacement.No other adverse event (ae)/product quality complaint (pqc) reported (no adverse event).Vacuum-induced hemorrhage control system (jada system) was not broken (i.E., the plastic breaks apart).It was difficult to connect/lost connection during preparation.Therapy with vacuum-induced hemorrhage control system (jada system) was withdrawn.The outcome of events was unknown.Upon internal review, the event device defective was considered 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: malfunction.Follow-up information has been received from quality investigation team on 21-mar-2024.This is a final report.Manufacturing statement: 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 would be re-opened, and additional investigation may be performed.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
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: 18845946
• Report Number: 3002806821-2024-00017
• Device Sequence Number: 15541676
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2025

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
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 01/31/2025
• 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