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

Device Problem Defective Device (2588)

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

Event Date 02/01/2024

Event Type  malfunction  

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 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.

• 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: 18845946
• MDR Text Key: 337331975
• Report Number: 3002806821-2024-00017
• 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: Physician
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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 Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female