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

Lot Number 1087321

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

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

Event Date 10/27/2023

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

After approximately 45 mins jada was removed, when it was noted that they were not able to achieve uterine tone with all other interventions and providers proceeded with c-hyst [device ineffective].Suction source for or (portable suction) fell off pph cart and to the floor when nurse retrieved pph cart prior to jada insertion.The fall sustained cracked the suction machine itself open and the suction canister was also cracked [device issue].Case narrative: this initial spontaneous report originating from the united states was received from an unspecified reported via clinical sales educator and designated point of contact (dpoc), referring to a female patient of unknown age.The patient's medical history was considered as pregnancy, delivery and b-lynch suture placement.Her concomitant medications included unspecified postpartum hemorrhage (pph) medications.Her past drugs and allergies were not reported.This report concerned 1 patient and 1 device.On (b)(6) 2023, the patient was inserted with vacuum-induced hemorrhage control system (jada system) via an unknown route for postpartum hemorrhage (pph) by an unspecified provider in the operating room (or) and 700 ml of blood was collected in the vacuum-induced hemorrhage control system (jada system) canister.However, the patient was unable to achieve uterine tone with multiple doses of pph medications and b-lynch suture placement.After approximately 45 minutes vacuum-induced hemorrhage control system (jada system) was removed, when it was noted that they were not able to achieve uterine tone with all other interventions, and the providers proceeded with hysterectomy (c-hyst) (device ineffective).After removal charge nurse noted that suction source for or (portable suction) fell off pph cart and to the floor when nurse retrieved pph cart prior to vacuum-induced hemorrhage control system (jada system) insertion.The fall sustained cracked the suction machine itself open and the suction canister was also cracked (device issue).The patient sought medical attention.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.For vacuum-induced hemorrhage control system (jada system), lot number and serial number were not provided.Upon internal review, the event of device ineffective was determined to be serious due to required intervention.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.

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

Suction source for or (portable suction) fell off pph cart and to the floor when nurse retrieved pph cart prior to jada insertion.The fall sustained cracked the suction machine itself open and the suction canister was also cracked [device issue].This was not a failure with jada system it was user error.[wrong technique in device usage process].No new ae [no adverse event].Case narrative: this initial spontaneous report originating from the united states was received from an unspecified reported via clinical sales educator and designated point of contact (dpoc), referring to a female patient of unknown age.The patient's medical history was considered as pregnancy, delivery and b-lynch suture placement.Her concomitant medications included unspecified postpartum hemorrhage (pph) medications.Her past drugs and allergies were not reported.This report concerned 1 patient and 1 device.On (b)(6) 2023, the patient was inserted with vacuum-induced hemorrhage control system (jada system) via an unknown route for postpartum hemorrhage (pph) by an unspecified provider in the operating room (or) and 700 ml of blood was collected in the vacuum-induced hemorrhage control system (jada system) canister.However, the patient was unable to achieve uterine tone with multiple doses of pph medications and b-lynch suture placement.After approximately 45 minutes vacuum-induced hemorrhage control system (jada system) was removed, when it was noted that they were not able to achieve uterine tone with all other interventions, and the providers proceeded with hysterectomy (c-hyst) (device ineffective).After removal charge nurse noted that suction source for or (portable suction) fell off pph cart and to the floor when nurse retrieved pph cart prior to vacuum-induced hemorrhage control system (jada system) insertion.The fall sustained cracked the suction machine itself open and the suction canister was also cracked (device issue).The patient sought medical attention.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.For vacuum-induced hemorrhage control system (jada system), lot number and serial number were not provided.Upon internal review, the event of device ineffective was determined to be serious due to required intervention.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.Follow up report received from consumer on 31-oct-2023.It was reported that, this was not a failure with vacuum-induced hemorrhage control system (jada system) it was user error (wrong technique in device usage process).States the physician and nurses rushed to operating room with the portable suction still plugged in and the machine and cannister fell and cracked.Suction was not functioning properly; because, it did not have a closed seal and the staff did not troubleshoot and find the cracks in the portable suction and cannister.Reporter stated when the patient was taken to the operating room, they did not attach vacuum-induced hemorrhage control system (jada system) to the wall suction as needed.Also, reported that she did not have specifics about the patient or outcome because there was poor documentation.It was stated that, there would be extensive training with staff concerning this issue.No new adverse event (no adverse event) and no product quality complain (pqc) reported.Upon internal review, the event of device issue was determined to be serious due to required intervention.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.

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.This case has been downgraded per internal review and no longer meets criteria for device reportable event.The report is being submitted one last time.

Event Description

This was not a failure with jada system it was user error/suction source for or (portable suction) fell off pph cart and to floor when nurse retrieved pph cart prior to jada insertion, fall sustained cracked suction machine, suction canister cracked.[wrong technique in device usage process].No new ae [no adverse event].Case narrative: this initial spontaneous report originating from the united states was received from an unspecified reported via clinical sales educator and designated point of contact (dpoc), referring to a female patient of unknown age.The patient's medical history was considered as pregnancy, delivery and b-lynch suture placement.Her concomitant medications included unspecified postpartum hemorrhage (pph) medications.Her past drugs and allergies were not reported.This report concerned 1 patient and 1 device.On (b)(6) 2023, the patient was inserted with vacuum-induced hemorrhage control system (jada system) via an unknown route for postpartum hemorrhage (pph) by an unspecified provider in the operating room (or) and 700 ml of blood was collected in the vacuum-induced hemorrhage control system (jada system) canister.However, the patient was unable to achieve uterine tone with multiple doses of pph medications and b-lynch suture placement.After approximately 45 minutes vacuum-induced hemorrhage control system (jada system) was removed, when it was noted that they were not able to achieve uterine tone with all other interventions, and the providers proceeded with hysterectomy (c-hyst) (device ineffective).After removal charge nurse noted that suction source for or (portable suction) fell off pph cart and to the floor when nurse retrieved pph cart prior to vacuum-induced hemorrhage control system (jada system) insertion.The fall sustained cracked the suction machine itself open and the suction canister was also cracked (device issue).The patient sought medical attention.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.For vacuum-induced hemorrhage control system (jada system), lot number and serial number were not provided.Upon internal review, the event of device ineffective was determined to be serious due to required intervention.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.Follow up report received from consumer on (b)(6) 2023.It was reported that, this was not a failure with vacuum-induced hemorrhage control system (jada system) it was user error (wrong technique in device usage process).States the physician and nurses rushed to operating room with the portable suction still plugged in and the machine and cannister fell and cracked.Suction was not functioning properly; because, it did not have a closed seal and the staff did not troubleshoot and find the cracks in the portable suction and cannister.Reporter stated when the patient was taken to the operating room, they did not attach vacuum-induced hemorrhage control system (jada system) to the wall suction as needed.Also, reported that she did not have specifics about the patient or outcome because there was poor documentation.It was stated that, there would be extensive training with staff concerning this issue.No new adverse event (no adverse event) and no product quality complain (pqc) reported.Upon internal review, the event of device issue was determined to be serious due to required intervention.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.Follow up information was received from nurse on (b)(6) 2023: the event device issue was deleted and the corresponding verbatim subsumed under the event wrong technique in device usage process.The case was downgraded as non-serious.The nurse reported that the patient's concurrent conditions included chronic hypertension.The patient had a history of chronic hypertension and a few other comorbidities that were not provided.The patient had no recorded history of abnormal postpartum uterine bleeding of hemorrhage.The patient was not diagnosed with endometritis, but she had a chorioamnionitis.This was the patient¿s third pregnancy although parity was not provided.The lmp and edd is not known.The current pregnancy type was singleton, the patient received a cesarean section after failure to progress, she received four rounds of misoprostol (cytotec) and had been on oxytocin (pitocin) for 24 hours.The exact gestational age at delivery us unknown but it was term.The patient received an epidural, and invasive placenta was not suspected.Further, confirmed no other vacuum-induced hemorrhage control system (jada system) was used but want to make sure they know it was not a closed seal suction for this device (lot# 1087321 and expiration date were not reported).The cannister and the portable suction we use to transfer the patient from the room to the operating room without losing suction had been dropped and it was cracked.There were notable bubbles in the tubing, it was not a closed seal.There were no further attempts and they did not try a different suction machine in the or even though there was one available.Bubbles were visible in the tubing.It was also reported that the operator of the device was the attending physician, it was their first-time using vacuum-induced hemorrhage control system (jada system).It was also confirmed the device was not removed and reinserted for any reason.The patient did not require admission to the intensive care unit (icu).The estimated total blood loss at delivery was 3,500 milliliter (ml) which includes the 700 ml in the vacuum-induced hemorrhage control system (jada system) cannister.The patient was not diagnosed for disseminated intravascular coagulation (dic).The patient did require blood products and received two units of whole blood, three units of packed red blood cells (prbcs), and two units of fresh frozen plasma (ffp).The reporter did not feel like the device failed just the suction.The reporter did not know the suspected cause of the postpartum hemorrhage and no further information available.This report is being downgraded due to that it is no longer serious injury.

• 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: 18046492
• MDR Text Key: 327043967
• Report Number: 3002806821-2023-00129
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: 1087321
• 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): Required Intervention
• Patient Sex: Female