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 12/31/2022

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

Hemoglobin of 4.7 [haemoglobin abnormal].Jada was inserted in the patient's room and then patient was taken to the operating room and had a d&c and a d&e (dilation and curettage, dilation and evacuation) [device ineffective].Bleeding around the seal after insertion [device leakage].Case narrative: this spontaneous report was received from clinical nurse specialist (cns) on behalf of provider via clinical nurse educator (cne), referring to a non-pregnant female patient of unknown age.The patient¿s medical history included on an unknown date in 2022, the patient became pregnant and was hospitalized in (b)(6) 2022 for delivery and the patient had vaginal delivery with 3 liters (l) of blood loss (also reported as it was unknown if that total was prior to use of vacuum-induced hemorrhage control system (jada system), during use of vacuum-induced hemorrhage control system (jada system), or after use of vacuum-induced hemorrhage control system (jada system)).The patient¿s concomitant therapies included methylergometrine maleate (methergine), misoprostol (cytotec), and multiple units of blood (doses and amounts were unknown).The patient's past drug reactions / allergies were not reported.This report concerns 1 patient and 1 device.On (b)(6) 2022, the patient had vacuum-induced hemorrhage control system (jada system) 2.0 placement via vaginal route by the attending physician in the patient's room for vaginal bleeding post birth (postpartum haemorrhage).The physician was not the first-time user and was an experienced user as a part of vacuum-induced hemorrhage control system (jada system) initiative.The physician reported that there was bleeding around the seal (device leakage) after insertion of the vacuum-induced hemorrhage control system (jada system).The patient was taken to the operating room and had dilation and curettage (d&c) and dilation and evacuation (d&e) (device ineffective).The cne thought patient was taken to the intensive care unit (icu) for a hemoglobin of 4.7 (units not reported) (haemoglobin abnormal) but was unsure how long the patient would have been in icu.The patient¿s hospitalization was prolonged due to the events.It was reported that the patient sought medical attention and was now recovered from bleeding.The vacuum-induced hemorrhage control system (jada system) device was not removed and re-inserted for any reasons and not more than one device was used.It was reported that the vacuum-induced hemorrhage control system (jada system) 2.0 came with a green carton and the vacuum-induced hemorrhage control system (jada system) stopped controlling the bleeding.There was no injury to the uterus occurred and disseminated intravascular coagulation (dic) was not diagnosed.On unknown date in (b)(6) 2023, the patient was discharged and hemoglobin at the time discharge was unknown.No cancer and overdose were reported.The patient did not die, and no significant disability or incapacity was reported.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 available.Therapy with vacuum-induced hemorrhage control system (jada system) was discontinued.The outcome of haemoglobin abnormal was unknown.The reporter's causality assessment was not provided.Upon internal review, the event of device ineffective was considered as serious due to required intervention.Medical device :serious injury.(b)(4).

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

Hemoglobin of 4.7 [haemoglobin abnormal].Jada was inserted in the patient's room and then patient was taken to the operating room and had a d&c and a d&e (dilation and curettage, dilation and evacuation)/bleeding around the seal after insertion [device ineffective].Case narrative: this spontaneous report was received from clinical nurse specialist (cns) on behalf of provider via clinical nurse educator (cne), referring to a non-pregnant female patient of unknown age.The patient¿s medical history included on an unknown date in 2022, the patient became pregnant and was hospitalized in (b)(6) 2022 for delivery and the patient had vaginal delivery with 3 liters (l) of blood loss (also reported as it was unknown if that total was prior to use of vacuum-induced hemorrhage control system (jada system), during use of vacuum-induced hemorrhage control system (jada system), or after use of vacuum-induced hemorrhage control system (jada system)).The patient¿s concomitant therapies included methylergometrine maleate (methergine), misoprostol (cytotec), and multiple units of blood (doses and amounts were unknown).The patient's past drug reactions / allergies were not reported.This report concerns 1 patient and 1 device.On (b)(6) 2022, the patient had vacuum-induced hemorrhage control system (jada system) 2.0 placement via vaginal route by the attending physician in the patient's room for vaginal bleeding post birth (postpartum haemorrhage).The physician was not the first-time user and was an experienced user as a part of vacuum-induced hemorrhage control system (jada system) initiative.The physician reported that there was bleeding around the seal (device leakage) after insertion of the vacuum-induced hemorrhage control system (jada system).The patient was taken to the operating room and had dilation and curettage (d&c) and dilation and evacuation (d&e) (device ineffective).The cne thought patient was taken to the intensive care unit (icu) for a hemoglobin of 4.7 (units not reported) (haemoglobin abnormal) but was unsure how long the patient would have been in icu.The patient¿s hospitalization was prolonged due to the events.It was reported that the patient sought medical attention and was now recovered from bleeding.The vacuum-induced hemorrhage control system (jada system) device was not removed and re-inserted for any reasons and not more than one device was used.It was reported that the vacuum-induced hemorrhage control system (jada system) 2.0 came with a green carton and the vacuum-induced hemorrhage control system (jada system) stopped controlling the bleeding.There was no injury to the uterus occurred and disseminated intravascular coagulation (dic) was not diagnosed.On unknown date in (b)(6) 2023, the patient was discharged and hemoglobin at the time discharge was unknown.No cancer and overdose were reported.The patient did not die, and no significant disability or incapacity was reported.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 available.Therapy with vacuum-induced hemorrhage control system (jada system) was discontinued.The outcome of haemoglobin abnormal was unknown.The reporter's causality assessment was not provided.Upon internal review, the event of device ineffective was considered as serious due to required intervention.Medical device :serious injury fda code: (health effects - health impact per annex f): 4608 intensive care (patient requires admission to or extension of stay in an intensive care unit).Fda code: (health effects - health impact per annex f): 4624 surgical intervention (one or more surgical procedures was required, or an existing procedure changed).Follow up information was received on 26-jan-2023.It was confirmed that there was no product quality complaint (pqc) reported at intake and the device itself was not leaking per report.The "leaking" described previously was related to the "bleeding" around the seal of the device.Hence the event device leakage was deleted.Bleeding around the seal of the device was subsumed in device ineffective event.

• 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: 16159957
• MDR Text Key: 307318103
• Report Number: 3002806821-2023-00002
• 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,Followup
• Report Date: 02/03/2023

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
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/13/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/03/2023
• 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
• Treatment: CYTOTEC (MISOPROSTOL),; CYTOTEC (MISOPROSTOL),; METHERGINE (METHYLERGOMETRINE MALEATE),; METHERGINE (METHYLERGOMETRINE MALEATE),
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female