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

Lot Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

Jada system was not successful in stopping the bleeding [device ineffective] reporting provider flushed the jada system after placing in uterus.[wrong technique in device usage process] no additional ae reported [no adverse event] case narrative: this spontaneous report originating from united states was received from a physician via clinical sales educator (cse), referring to a non-pregnant female patient of unknown age.The patient¿s historical condition included cesarean section.The patient's current condition, 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 underwent insertion with vacuum-induced hemorrhage control system (jada system) (lot # and expiration date were not reported) via intravaginal route for postpartum bleeding.The physician flushed the vacuum-induced hemorrhage control system (jada system) after placing in uterus.The physician was told by nurses that instructions for use (ifu) did not give that direction.The physician did not do multiple sweeps.The vacuum-induced hemorrhage control system (jada system) had to be removed.The vacuum-induced hemorrhage control system (jada system) was not successful in stopping the bleeding (device ineffective).No additional adverse event (ae) (no adverse event) reported.The patient sought medical attention.The vacuum-induced hemorrhage control system (jada system) did not stop control the bleeding.The vacuum-induced hemorrhage control system (jada system) worked without issue, but the bleeding continued.The delivery method of the current pregnancy was cesarean section.The operator was not using first time vacuum-induced hemorrhage control system (jada system).The device was not removed and reinserted for any reason.There was not more than one vacuum-induced hemorrhage control system (jada system) device used.Therapy with vacuum-induced hemorrhage control system (jada system) was withdrawn.The outcome of the events was unknown.Upon internal review, the event device ineffective was determined to be medically significant.When the lot number is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.Fda code: (health effects - health impact per annex f): 4641 unexpected medical intervention (patient required an unforeseen medical intervention, excluding surgery, which was not on the original treatment plan).

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.

• 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: 18779549
• MDR Text Key: 336295157
• Report Number: 3002806821-2024-00008
• 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: 02/26/2024

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
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2024
• 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