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

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

Patient Problems Hemorrhage/Bleeding (1888); Insufficient Information (4580)

Event Date 01/01/2024

Event Type  Injury  

Event Description

Still pouring blood [device ineffective] while closing the abdomen, the hcp "nicked" the jada but reports that the patient was "still pouring blood" prior to nicking the jada [device use issue] case narrative: this spontaneous report was received from an other healthcare professional via clinical account specialist (cas) referring to a non-pregnant female patient of unknown age.The patient's medical history included: on an unknown date in last week a patient had an induction of labor with cytotec and pitocin.The patient required a cesarean section due to a "prolonged second stage" of labor and fetal "macrosomia".The gestational age at delivery was full term.The patient was taken to the intensive care unit (icu) for "less than 24 hours" and was discharged in a normal amount of time.The patient was nulliparous (p0) with gravida i (g1) (concurrent condition).The patient¿s historical drug included cytotec and pitocin for induction of labor.Concomitant therapies were not reported.This report concerns 1 patient(s) and 1 device(s).On unknown date in (b)(6) 2024 (reported as last week), the patient underwent insertion with vacuum-induced hemorrhage control system (jada system) (lot # and expiration date were not reported) via intravaginal route for postpartum uterine bleeding or hemorrhage.After insertion of jada 700 (unit not reported) blood was collected in the canister.On unknown date in (b)(6) 2024, the healthcare professional (hcp) noted bleeding during the cesarean section and placed the jada prior to closing the abdomen.While closing the abdomen, the hcp "nicked" the jada but reported that the patient was "still pouring blood" prior to nicking the jada (device ineffective) (device use issue).The estimated total blood loss at delivery was 2500 ml.Due to so much blood loss the patient received "methergine, txa, and pitocin" and a "b lynch suture" but subsequently required a hysterectomy.It was reported that the patient recovered from the state.The patient sought medical attention.One jada device was only used.No additional information provided.No additional ae/pqc reported.For vacuum-induced hemorrhage control system (jada system), the lot number and the serial number was not available.Upon internal review, the event device ineffective was considered 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 could not be performed.Medical device reporting criteria: serious 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

Still pouring blood [device ineffective].While closing the abdomen, the hcp "nicked" the jada but reports that the patient was "still pouring blood" prior to nicking the jada/uterus did not respond to it [device use issue].Case narrative: this spontaneous report was received from an other healthcare professional via clinical account specialist (cas) referring to a non-pregnant female patient of unknown age.The patient's medical history included: on an unknown date in last week a patient had an induction of labor with cytotec and pitocin.The patient required a cesarean section due to a "prolonged second stage" of labor and fetal "macrosomia".The gestational age at delivery was full term.The patient was taken to the intensive care unit (icu) for "less than 24 hours" and was discharged in a normal amount of time.The patient was nulliparous (p0) with gravida i (g1) (concurrent condition).The patient¿s historical drug included cytotec and pitocin for induction of labor.Concomitant therapies were not reported.This report concerns 1 patient(s) and 1 device(s).On unknown date in (b)(6) 2024 (reported as last week), the patient underwent insertion with vacuum-induced hemorrhage control system (jada system) (lot # and expiration date were not reported) via intravaginal route for postpartum uterine bleeding or hemorrhage.After insertion of jada 700 (unit not reported) blood was collected in the canister.On unknown date in (b)(6) 2024, the healthcare professional (hcp) noted bleeding during the cesarean section and placed the jada prior to closing the abdomen.While closing the abdomen, the hcp "nicked" the jada but reported that the patient was "still pouring blood" prior to nicking the jada (device ineffective) (device use issue).The estimated total blood loss at delivery was 2500 ml.Due to so much blood loss the patient received "methergine, txa, and pitocin" and a "b lynch suture" but subsequently required a hysterectomy.It was reported that the patient recovered from the state.The patient sought medical attention.One jada device was only used.No additional information provided.No additional ae/pqc reported.For vacuum-induced hemorrhage control system (jada system), the lot number and the serial number was not available.Upon internal review, the event device ineffective was considered 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 could not be performed.Medical device reporting criteria: serious injury.Follow up information received from physician on 17-jan-2024.The provider stated that there was no adverse event with the jada system.The uterus did not respond to it and the device worked fine.The provider stated there was no further information on the event.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 could not be performed.Medical device reporting criteria: serious 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.

• 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: 18516523
• MDR Text Key: 332882709
• Report Number: 3002806821-2024-00001
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female