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

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 05/01/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

First the device was inserted and when the balloon was being inflated, the balloon burst [device breakage].Case narrative: this initial spontaneous report originating from the united states, was received from a physician assistant (also reported as healthcare professional (hcp)) via clinical accounts specialist (cas), referring to a non-pregnant female patient of unknown age.The patient's past drugs/ allergies, concurrent conditions and concomitant medications were not reported.Her medical history included pregnancy.This report concerns 1 patient and 1 device (suspected device).On an unknown date in (b)(6)2023 (reported as "last week"), the patient was inserted with vacuum-induced hemorrhage control system (jada system) (#1) via intravaginal route for a significantly delayed postpartum hemorrhage (lot #, serial # and expiration date were not reported) by the physician assistant and when the balloon was being inflated, the balloon burst (device breakage).The cas did not know how much fluid was inserted into the balloon.Device was removed and a new vacuum-induced hemorrhage control system (jada system) (#2) device was inserted that worked as expected.It was also reported that the patient had sought medical attention, and treatment was given for adverse event (ae) (discrepancy).The vacuum-induced hemorrhage control system (jada system) (#1) was not available for evaluation as it was discarded.Upon internal review, the event of device breakage was considered as serious as it 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.Therefore, priority quality investigation will not be completed.Medical device reporting criteria: malfunction, serious injury.Fda code (health effects-health impact per annex f): 4648 insufficient information (there is not yet enough information available to classify the health impact).Fda code (health effects-health impact per annex f): 4641 unexpected medical intervention (patient required an unforeseen medical intervention, excluding surgery, which was not on the original treatment plan).

Event Description

First the device was inserted and when the balloon was being inflated, the balloon burst [device breakage] case narrative: this initial spontaneous report originating from the united states, was received from a physician assistant (also reported as healthcare professional (hcp)) via clinical accounts specialist (cas), referring to a non-pregnant female patient of unknown age.The patient's past drugs/ allergies, concurrent conditions and concomitant medications were not reported.Her medical history included pregnancy.This report concerns 1 patient and 1 device (suspected device).On an unknown date in may 2023 (reported as "last week"), the patient was inserted with vacuum-induced hemorrhage control system (jada system) (#1) via intravaginal route for a significantly delayed postpartum hemorrhage (lot #, serial # and expiration date were not reported) by the physician assistant and when the balloon was being inflated, the balloon burst (device breakage).The cas did not know how much fluid was inserted into the balloon.Device was removed and a new vacuum-induced hemorrhage control system (jada system) (#2) device was inserted that worked as expected.It was also reported that the patient had sought medical attention, and treatment was given for adverse event (ae) (discrepancy).The vacuum-induced hemorrhage control system (jada system) (#1) was not available for evaluation as it was discarded.Upon internal review, the event of device breakage was considered as serious as it 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.Therefore, priority quality investigation will not be completed.Medical device reporting criteria: malfunction, serious injury.Fda code (health effects-health impact per annex f): 4648 insufficient information (there is not yet enough information available to classify the health impact).Fda code (health effects-health impact per annex f): 4641 unexpected medical intervention (patient required an unforeseen medical intervention, excluding surgery, which was not on the original treatment plan).This is an amended report.The field ¿adverse event¿ box was checked in medwatch of analysis tab.

Manufacturer Narrative

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

Event Description

First the device was inserted and when the balloon was being inflated, the balloon burst [device breakage].Case narrative: this initial spontaneous report originating from the united states, was received from a physician assistant (also reported as healthcare professional (hcp)) via clinical accounts specialist (cas), referring to a non-pregnant female patient of unknown age.The patient's past drugs/ allergies, concurrent conditions and concomitant medications were not reported.Her medical history included pregnancy.This report concerns 1 patient and 1 device (suspected device).On an unknown date in (b)(6) 2023 (reported as "last week"), the patient was inserted with vacuum-induced hemorrhage control system (jada system) (#1) via intravaginal route for a significantly delayed postpartum hemorrhage (lot #, serial # and expiration date were not reported) by the physician assistant and when the balloon was being inflated, the balloon burst (device breakage).The cas did not know how much fluid was inserted into the balloon.Device was removed and a new vacuum-induced hemorrhage control system (jada system) (#2) device was inserted that worked as expected.It was also reported that the patient had sought medical attention, and treatment was given for adverse event (ae) (discrepancy).The vacuum-induced hemorrhage control system (jada system) (#1) was not available for evaluation as it was discarded.Upon internal review, the event of device breakage was considered as serious as it 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.Therefore, priority quality investigation will not be completed.Medical device reporting criteria: malfunction, serious injury.Fda code (health effects-health impact per annex f): 4648 insufficient information (there is not yet enough information available to classify the health impact).Fda code (health effects-health impact per annex f): 4641 unexpected medical intervention (patient required an unforeseen medical intervention, excluding surgery, which was not on the original treatment plan).This is an amended report.The field ¿adverse event¿ box was checked in medwatch of analysis tab.Follow-up information has been received on 22-nov-2023.It was reported that no complaint sample or device lot number are available for evaluation, therefore an unknown investigation was performed.The device is assembled per specifications where in-process and final inspections are conducted by trained personnel.No outcome from the investigation could be determined since no complaint sample or lot identification had been provided.If the complaint sample or lot number become available, this complaint will be re-opened, and additional investigation may be performed.

Manufacturer Narrative

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: 17011483
• MDR Text Key: 316103683
• Report Number: 3002806821-2023-00063
• 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: Physician Assistant
• Type of Report: Initial,Followup,Followup
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female