MAUDE Adverse Event Report: ORGANON & CO. JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM

Lot Number UNKNOWN

Device Problems Leak/Splash (1354); Mechanical Problem (1384)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/02/2024

Event Type  malfunction  

Event Description

¿we aren¿t sure if there was a charting error or a leak in the seal.The charting says 120 ccs were placed in the seal, but when removed there was only 50 ccs able to be removed [circumstance or information capable of leading to device use error] no additional ae reported, no pqc reported.[no adverse event] case narrative: this spontaneous report originating from united states was received from other health professional (nurse) via designated point of contact (dpoc) 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).On an unknown date, the patient was inserted with the vacuum-induced hemorrhage control system (jada system) (route, batch/lot# and expiry date were not reported) for an unknown indication.On an unknown date, it was reported that the charting said 120 ccs were placed in the seal, but when removed there was only 50 ccs able to be removed.The health care professional (hcp) was not sure if there was a charting error or a leak in the seal.(circumstance or information capable of leading to device use error).No additional adverse event (ae) or product quality complaint (pqc) was reported.(no adverse event).Upon internal review, the event circumstance or information capable of leading to device use error was considered to be medical 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.

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.

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 Description

¿we aren¿t sure if there was a charting error or a leak in the seal.The charting says 120 ccs were placed in the seal, but when removed there was only 50 ccs able to be removed [circumstance or information capable of leading to device use error] no additional ae reported, no pqc reported.[no adverse event].Case narrative: this spontaneous report originating from united states was received from other health professional (nurse) via designated point of contact (dpoc) 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).On (b)(6) 2024, the patient was inserted with the vacuum-induced hemorrhage control system (jada system) (route, batch/lot# and expiry date were not reported) for an unknown indication.On 02-jan-2024, it was reported that the charting said 120 ccs were placed in the seal, but when removed there was only 50 ccs able to be removed.The health care professional (hcp) was not sure if there was a charting error or a leak in the seal.(circumstance or information capable of leading to device use error).No additional adverse event (ae) or product quality complaint (pqc) was reported.(no adverse event).Upon internal review, the event circumstance or information capable of leading to device use error was considered to be medical 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.This is an amended report to updated event onset date as 02-jan-2024.Device available for evalution updated to no.Updated patient problem and device problem information as per drr.

• 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 Key: 18807521
• MDR Text Key: 336561756
• Report Number: 3002806821-2024-00013
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 510K K201199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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 Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female