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 Date 05/12/2023

Event Type  Injury  

Event Description

Jada device back in" and no blood came out.The patient still had uterine atony [device ineffective].Nicks to the bladder and lower pelvic abdominal area [bladder injury].Nicks to the bladder and lower pelvic abdominal area [abdominal injury].The provider removed the jada then did a uterine sweep and placed "either another jada device or the same jada device back in" [wrong technique in device usage process].Case narrative: this initial spontaneous report originating from the united states, was received from an unspecified nurse educator via clinical account specialist (cas) referring to a female patient of unknown age.The cas reported that patient was pregnant and had gotten to 9 cm cervical dilation but was unable to deliver vaginally for unknown reasons.So, she had an urgent caesarean-section as a last effort, and it was a full-term delivery.The patient became hypotensive in the post-anesthesia care unit (pacu) with no vaginal bleeding.The provider took the patient back to the operating room and the nurse educator stated that all she knew was that "they called an overhead rapid response for all hands on deck".A massive transfusion protocol was performed.The provider did not perform a "sweep" before placement of vacuum-induced hemorrhage control system (jada system).The patient's concurrent conditions also included hospitalization, uterine atony, gravida 2 and para 1.Her concomitant drugs, historical drugs and allergies were not reported.This report concerns 1 patient and 1 device.On (b)(6) 2023, the physician placed vacuum-induced hemorrhage control system (jada system) via unknown route (lot #, serial # and expiration date were not reported) for an unknown indication (product used for unknown indication).Reportedly, it was placed after transfusion.The vacuum-induced hemorrhage control system (jada system) was hooked up to suction and 1100 cc of blood was collected.The provider removed the vacuum-induced hemorrhage control system (jada system) then did a uterine sweep and at that point the provider placed "either another vacuum-induced hemorrhage control system (jada system) device or the same vacuum-induced hemorrhage control system (jada system) device back in" (wrong technique in device usage process) and no blood came out.The patient still had uterine atony (device ineffective).The vacuum-induced hemorrhage control system (jada system) device was removed on the same day.The provider ended up removing the patient's uterus and then the patient went to the intensive care unit (icu) (hospitalization prolonged).In the icu the patient "coded" at some point but was still alive at the time of this report.It was determined after uterus was removed that the patient had nicks to the bladder and lower pelvic abdominal area (bladder injury, and abdominal injury).The patient was left open in icu before the providers took her back and "closed her up".Patient was transferred by air to a different health facility.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.The outcome of the events of bladder injury and abdominal injury was not recovered (reported as patient status not recovered).Upon internal review, the event of device ineffective was considered serious as it required intervention.Upon internal review, the event of bladder injury 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): 4624 surgical intervention (one or more surgical procedures was required, or an existing procedure changed).

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: 16986351
• MDR Text Key: 315846024
• Report Number: 3002806821-2023-00060
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• 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?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Hospitalization
• Patient Sex: Female