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 08/25/2023

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

Patient was on suction, but reporter was not sure how long before bleeding was noticed around the seal [device ineffective].Case narrative: this spontaneous report originating from united states was received from a nurse via clinical sales educator (cse), referring to a 21-year-old adult female patient.It was reported that the patient had no past medical history and no pertinent medical history.The patient's concomitant medications, and drug reactions/allergies were not reported.The patient's medical history and concurrent condition included: on an unknown date approximately in (b)(6) 2022, the patient became pregnant (reported as full-term pregnancy).In (b)(6) 2023, the patient was hospitalized for the delivery and gave birth to her first baby (full-term) via vaginal delivery on (b)(6) 2023.It was reported that the patient started bleeding after delivery with no uterotonic medications administered initially.This report concerned 1 patient and 1 device.On (b)(6) 2023, the patient had first vacuum-induced hemorrhage control system (jada system) (#1) placement via intrauterine route (lot# and expiration date were not reported) for post-partum hemorrhage.The patient was on suction, but the reporter was not sure how long before bleeding was noticed around the seal (device ineffective), and it led to prolongation of hospitalization.The vacuum-induced hemorrhage control system (jada system) (#1) was removed on (b)(6) 2023, and a second new vacuum-induced hemorrhage control system (jada system) device (#2) was placed on (b)(6) 2023.For vacuum-induced hemorrhage control system (jada system), the lot number and the serial number were not available.Clinical sales educator had not spoken with the provider directly and stated that it was unknown if the hemorrhage was due to atony or any other source of bleeding.No additional adverse event (ae)/ product quality complaint (pqc) reported.No further information provided.Upon internal review, the event of device ineffective was considered to be medically significant.This case is one of two reports derived for the same patient.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): 4607 - hospitalization or prolonged hospitalization (hospitalization or prolonged hospitalization due to the health damage accompanying the use of device.) 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).

• 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: 17797672
• MDR Text Key: 324014918
• Report Number: 3002806821-2023-00114
• 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): Other; Hospitalization
• Patient Age: 21 YR
• Patient Sex: Female