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

Lot Number 1070324

Device Problems Inflation Problem (1310); Infusion or Flow Problem (2964); Material Deformation (2976); Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 10/13/2022

Event Type  Injury  

Event Description

Could not obtain a good cervical seal with the device/ upon inspection of the jada(1) there was a pinhole noted in the cervical seal balloon [device material issue] could not obtain a good cervical seal with the device/ upon inspection of the jada(1) there was a pinhole noted in the cervical seal balloon [poor quality device used] case narrative: this spontaneous report was received from a nurse on behalf of physician via clinical account specialist (cas), referring to a 25-year-old female patient.The patient had no known drug allergies (nkda).The patient¿s medical history included pregnancy, singleton and had delivery.The patient¿s concurrent conditions included hypertension, asthma, obesity, uterine atony, and hospitalization.The patient¿s concomitant medication included 1000 micrograms (mg) of misoprostol, 2 bags of oxytocin, and tranexamic acid (txa).This report concerned 1 patient and 1 device.The reporter stated that patient second baby was delivered when she was 39 weeks and 3 days.The delivery type was reported as cesarean.Patient received a ¿spinal¿ for the cesarean.The pregnancy outcome and date were not reported.The fetal outcome was not reported.There was no invasive placenta.On (b)(6) 2022, the patient was inserted with first vacuum-induced hemorrhage control system (jada system) via vaginal route (lot#: 1070324 and expiration date reported as 06-apr-2025) for post-delivery hemorrhage (postpartum hemorrhage).When the physician attempted the use first vacuum-induced hemorrhage control system (jada system) they were unable to obtain a good seal and found a pinpoint hole in the cervical seal (poor-quality device used) and could not achieve the correct amount of suction.The patient¿s hospitalization was prolonged due to the events.The nurse requested the cas for the advice and had advised to increase the suction, but the physician opted not to increase the suction.The device was removed.The first vacuum-induced hemorrhage control system (jada system) was not available for retrieval.On the same day, the patient was inserted with second vacuum-induced hemorrhage control system (jada system) via vaginal route successfully.Both vacuum-induced hemorrhage control system (jada system) received with green carton.The first vacuum-induced hemorrhage control system (jada system) did not control the bleeding, but the second vacuum-induced hemorrhage control system (jada system) device did.The patient sought medical attention.It was reported that the patient was recovered, and recovery date was reported as (b)(6) 2022.No escalating treatments were required after vacuum-induced hemorrhage control system (jada system).It was reported that prior to the vacuum-induced hemorrhage control system (jada system) 1727 cubic centimeter (cc) blood loss was estimated to insertion.After insertion, 112 cubic centimeter (cc) blood was collected, and caller stated that the patient was not bleeding heavily after removal of vacuum-induced hemorrhage control system (jada system) and there were no pad weights in the chart.That not heavily bleeding after removal.It was reported that patient did not require admission to the intensive care unit (icu) and was not diagnosed with endometritis.Disseminated intravascular coagulation (dic) was not diagnosed and no other blood products were required.Medical device reporting criteria: malfunction and serious injury.(b)(4).

Manufacturer Narrative

The investigation is currently ongoing: a follow up report will be submitted on completion of the investigation.

Event Description

Could not obtain a good cervical seal with the device/ upon inspection of the jada(1).There was a pinhole noted in the cervical seal balloon [device material issue].Could not obtain a good cervical seal with the device/ upon inspection of the jada(1).There was a pinhole noted in the cervical seal balloon [poor quality device used].Case narrative: this spontaneous report was received from a nurse on behalf of physician via clinical account specialist (cas), referring to a 25-year-old female patient.The patient had no known drug allergies (nkda).The patient¿s medical history included pregnancy, singleton and had delivery.The patient¿s concurrent conditions included hypertension, asthma, obesity, uterine atony, and hospitalization.The patient¿s concomitant medication included 1000 micrograms (mg) of misoprostol, 2 bags of oxytocin, and tranexamic acid (txa).This report concerned 1 patient and 1 device.The reporter stated that patient second baby was delivered when she was 39 weeks and 3 days.The delivery type was reported as cesarean.Patient received a ¿spinal¿ for the cesarean.The pregnancy outcome and date were not reported.The fetal outcome was not reported.There was no invasive placenta.On (b)(6) 2022, the patient was inserted with first vacuum-induced hemorrhage control system (jada system) via vaginal route (lot#: 1070324 and expiration date reported as 06-apr-2025) for post-delivery hemorrhage (postpartum hemorrhage).When the physician attempted the use first vacuum-induced hemorrhage control system (jada system) they were unable to obtain a good seal and found a pinpoint hole in the cervical seal (poor-quality device used) and could not achieve the correct amount of suction.The patient¿s hospitalization was prolonged due to the events.The nurse requested the cas for the advice and had advised to increase the suction, but the physician opted not to increase the suction.The device was removed.The first vacuum-induced hemorrhage control system (jada system) was not available for retrieval.On the same day, the patient was inserted with second vacuum-induced hemorrhage control system (jada system) via vaginal route successfully.Both vacuum-induced hemorrhage control system (jada system) received with green carton.The first vacuum-induced hemorrhage control system (jada system) did not control the bleeding, but the second vacuum-induced hemorrhage control system (jada system) device did.The patient sought medical attention.It was reported that the patient was recovered, and recovery date was reported as (b)(6) 2022.No escalating treatments were required after vacuum-induced hemorrhage control system (jada system).It was reported that prior to the vacuum-induced hemorrhage control system (jada system) 1727 cubic centimeter (cc) blood loss was estimated to insertion.After insertion, 112 cubic centimeter (cc) blood was collected, and caller stated that the patient was not bleeding heavily after removal of vacuum-induced hemorrhage control system (jada system) and there were no pad weights in the chart.That not heavily bleeding after removal.It was reported that patient did not require admission to the intensive care unit (icu) and was not diagnosed with endometritis.Disseminated intravascular coagulation (dic) was not diagnosed and no other blood products were required.Medical device reporting criteria: malfunction and serious injury.Health effects-health impact--fda code: 4641 unexpected medical intervention (patient required an unforeseen medical intervention, excluding surgery, which was not on the original treatment plan).This was a final device related report.Investigation has been completed, and based on the information received, there was currently no indication that a nonconforming device was manufactured.No complaint sample was available for inspection at the time of this evaluation.The device was assembled according to specifications.In process and finished product testing are performed and approved prior to release.One complaint sample was available for inspection at the location where the event occurred.From the evidence provided, the balloon defect of ¿pinhole¿ was verified.The investigation has been completed, and based on the updated information received, there was currently no indication that a nonconforming device was manufactured.Device history records, deviations, incoming inspection, and corrective and preventive actions (capa) reviews were performed with no non-conformances noted.The device was assembled per specifications where in-process and final inspections are conducted by trained personnel.During assembly balloons are inflated with 220 milliliters (ml) of air, submerged in 99 percent (%) alcohol and checked for leaks and bubbles along the balloon.Operations would have observed this type of defect during in-process testing.Any units failing this 100% verification are discarded.The root cause cannot be determined being the device was used and there are no indications that the device was released as nonconforming.

Manufacturer Narrative

Investigation has been completed, and based on the information received, there was currently no indication that a nonconforming device was manufactured.No complaint sample was available for inspection at the time of this evaluation.The device was assembled according to specifications.In process and finished product testing are performed and approved prior to release.One complaint sample was available for inspection at the location where the event occurred.From the evidence provided, the balloon defect of ¿pinhole¿ was verified.The investigation has been completed, and based on the updated information received, there was currently no indication that a nonconforming device was manufactured.Device history records, deviations, incoming inspection, and corrective and preventive actions (capa) reviews were performed with no non-conformances noted.The device was assembled per specifications where in-process and final inspections are conducted by trained personnel.During assembly balloons are inflated with 220 milliliters (ml) of air, submerged in 99 percent (%) alcohol and checked for leaks and bubbles along the balloon.Operations would have observed this type of defect during in-process testing.Any units failing this 100% verification are discarded.The root cause cannot be determined being the device was used and there are no indications that the device was released as nonconforming.

• 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: 15780990
• MDR Text Key: 303556411
• Report Number: 3002806821-2022-00004
• 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: Other,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 1070324
• Was Device Available for Evaluation?: No
• 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
• Treatment: MISOPROSTOL (MISOPROSTOL),; MISOPROSTOL (MISOPROSTOL),; OXYTOCIN (OXYTOCIN),; OXYTOCIN (OXYTOCIN),; TRANEXAMIC ACID (TRANEXAMIC ACID),; TRANEXAMIC ACID (TRANEXAMIC ACID),
• Patient Outcome(s): Hospitalization
• Patient Age: 25 YR
• Patient Sex: Female