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 Laceration(s) (1946)

Event Date 07/24/2023

Event Type  Injury  

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.

Event Description

Laceration [uterine cervical laceration] provider placed jada and "it worked", but while provider was repairing a laceration, he "put a suture through the cervical seal.[device use issue].Case narrative: this initial spontaneous report originating from the united states was received from an unspecified member of hospital staff via clinical account specialist (cas), referring to a female patient of unknown age.The patient's medical history included vaginal delivery and pregnancy.Reportedly, she developed uterine atony while laboring.Her concomitant medications and past drug reactions/allergies were not reported.This report concerns 1 patient and 1 device.On (b)(6), 2023, the patient was inserted with vacuum-induced hemorrhage control system (jada system) via intrauterine route by the attending physician for postpartum hemorrhage.It worked, but while the provider was repairing a laceration (uterine cervical laceration), he "put a suture through the cervical seal" (device use issue) (presumably as a treatment).The device was removed and "the patient was fine".Reportedly, the patient received 2 units of blood, but it was not known where in the process that occurred.The outcome of uterine cervical laceration was unknown.The causality assessment was not provided.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.For vacuum-induced hemorrhage control system (jada system) lot number and serial number were not provided.Upon internal review, the event of uterine cervical laceration was considered as 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): 4643 blood transfusion (patient required an infusion of whole blood or a blood component directly into the bloodstream).

• 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: 17412554
• MDR Text Key: 319925435
• Report Number: 3002806821-2023-00093
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• PMA/PMN Number: 510K K201199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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