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

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Event Description

Jada was placed but blood was "rapidly collecting in the (suction) canister, approximately 500ml and with more blood rapidly collecting -device ineffective.Case narrative: this spontaneous report originating from the united states was received from a nurse via clinical account specialist (cas), referring to a female patient of an unknown age.The patient's historical conditions included pregnancy and delivery.Her current condition included hospitalization.Her past drugs/ allergies and concomitant medications were not reported.This report concerns 1 patient and 1 device.On an unknown date, the patient was in the operating room for postpartum hemorrhage and vacuum-induced hemorrhage control system (jada system) was placed via intrauterine route by an unspecified provider, however, blood was rapidly collecting in the (suction) canister, approximately 500 ml and with more blood rapidly collecting (device ineffective).The provider decided to move on to alternative interventions (further unspecified) to control the bleeding.The vacuum-induced hemorrhage control system (jada system) was removed, and bleeding was controlled after bakri was placed.No further information was provided.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.For vacuum-induced hemorrhage control system (jada system), lot number and serial number were not provided.Upon internal review, the event of device ineffective was considered to be serious due to required intervention.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): 4642 additional device required (use of an additional or alternative device require to achieve optimal outcome.).

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: 17797402
• MDR Text Key: 324008055
• Report Number: 3002806821-2023-00112
• 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
• Report Date: 09/22/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2023
• 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): Required Intervention
• Patient Sex: Female