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

Lot Number 1070327

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

Patient Problem Insufficient Information (4580)

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

While hooking up the jada they couldn't get it to work, device ineffective.Case narrative: this initial spontaneous report originating from the united states, was received from a nurse manager of labor & delivery (also reported as registered nurse) via clinical account specialist (cas) and designated point of contact (dpoc) at the, referring to a non-pregnant female patient of unknown age.The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported.This report concerned 1 patient and 2 devices.On an unknown date, the patient was inserted with vacuum-induced hemorrhage control system (jada system) (#1) via vaginal route (lot# and expiry date were not reported) for postpartum hemorrhage by the physician (reported as provider) and while hooking up the vacuum-induced hemorrhage control system (jada system) (#1), they could not get it to work (device ineffective).The patient sought for medical attention.Provider reported the suction would not work on the vacuum-induced hemorrhage control system (jada system) (#1) after it was inserted and attached to the functioning wall suction.However, nothing appeared to be broken.Provider reported there might have been a blood clot on the suction port preventing the suction from functioning, but he was unsure.Therapy with the vacuum-induced hemorrhage control system (jada system) (#1) was discontinued.Another vacuum-induced hemorrhage control system (jada system) (#2) was used (with lot# 1070327 and expiry date 03-may-2025) and it worked appropriately.The vacuum-induced hemorrhage control system (jada system) (#1) was available for retrieval, and the provider was requesting for a replacement.It was reported defective vacuum-induced hemorrhage control system (jada system) (#1) passed the series of tests and no defect was found.The cas informed that the defective device might have been discarded after testing and there was not a system for them to return contaminated material from defective products anyway.Upon internal review, the event of device ineffective was determined to be medically significant.Medical device: serious injury 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).

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

While hooking up the jada they couldn't get it to work [device ineffective].Case narrative: this initial spontaneous report originating from the united states, was received from a nurse manager of labor & delivery (also reported as registered nurse) via clinical account specialist (cas) and designated point of contact (dpoc) at the, referring to a non-pregnant female patient of unknown age.The patients concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported.This report concerned 1 patient and 2 devices.On an unknown date, the patient was inserted with vacuum-induced hemorrhage control system (jada system) (#1) via vaginal route (lot# and expiry date were not reported) for postpartum hemorrhage by the physician (reported as provider) and while hooking up the vacuum-induced hemorrhage control system (jada system) (#1), they could not get it to work (device ineffective).The patient sought for medical attention.Provider reported the suction would not work on the vacuum-induced hemorrhage control system (jada system) (#1) after it was inserted and attached to the functioning wall suction.However, nothing appeared to be broken.Provider reported there might have been a blood clot on the suction port preventing the suction from functioning, but he was unsure.Therapy with the vacuum-induced hemorrhage control system (jada system) (#1) was discontinued.Another vacuum-induced hemorrhage control system (jada system) (#2) was used (with lot#: 1070327 and expiry date 03-may-2025) and it worked appropriately.The vacuum-induced hemorrhage control system (jada system) (#1) was available for retrieval, and the provider was requesting for a replacement.It was reported defective vacuum-induced hemorrhage control system (jada system) (#1) passed the series of tests and no defect was found.The cas informed that the defective device might have been discarded after testing and there was not a system for them to return contaminated material from defective products anyway.Upon internal review, the event of device ineffective was determined to be medically significant.Medical device: serious injury.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).Follow up information was received from the cas via dpoc on 08-mar-2023.The lot number of vacuum-induced hemorrhage control system (jada system) (#1) was reported as 1070327.Medical device: serious injury.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).

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

While hooking up the jada they couldn't get it to work [device ineffective].Case narrative: this initial spontaneous report originating from the united states, was received from a nurse manager of labor & delivery (also reported as registered nurse) via clinical account specialist (cas) and designated point of contact (dpoc) at the, referring to a non-pregnant female patient of unknown age.The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported.This report concerned 1 patient and 2 devices.On an unknown date, the patient was inserted with vacuum-induced hemorrhage control system (jada system) (#1) via vaginal route (lot# and expiry date were not reported) for postpartum hemorrhage by the physician (reported as provider) and while hooking up the vacuum-induced hemorrhage control system (jada system) (#1), they could not get it to work (device ineffective).The patient sought for medical attention.Provider reported the suction would not work on the vacuum-induced hemorrhage control system (jada system) (#1) after it was inserted and attached to the functioning wall suction.However, nothing appeared to be broken.Provider reported there might have been a blood clot on the suction port preventing the suction from functioning, but he was unsure.Therapy with the vacuum-induced hemorrhage control system (jada system) (#1) was discontinued.Another vacuum-induced hemorrhage control system (jada system) (#2) was used (with lot# 1070327 and expiry date 03-may-2025) and it worked appropriately.The vacuum-induced hemorrhage control system (jada system) (#1) was available for retrieval, and the provider was requesting for a replacement.It was reported defective vacuum-induced hemorrhage control system (jada system) (#1) passed the series of tests and no defect was found.The cas informed that the defective device might have been discarded after testing and there was not a system for them to return contaminated material from defective products anyway.Upon internal review, the event of device ineffective was determined to be medically significant.Medical device: serious injury 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) follow up information was received from the cas via dpoc on 08-mar-2023.The lot number of vacuum-induced hemorrhage control system (jada system) (#1) was reported as 1070327.Medical device: serious injury 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 final report.Complaint sample is not available for investigation.Review elements of the event included lot record package (dhr), non-conformances, manufacturing controls, capa log and complaint trends.The device is assembled per specifications where in-process and final inspections are conducted by trained personnel.In process and finished product testing is performed and approved prior to release.Based on the information received, there is no indication that the device malfunctioned.If the complaint sample becomes available, this complaint will be re-opened and additional investigation may be performed.

• 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: 16385059
• MDR Text Key: 309644947
• Report Number: 3002806821-2023-00013
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2023

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
• Device Lot Number: 1070327
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2023
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/20/2023; 05/05/2023
• 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
• Patient Outcome(s): Other
• Patient Sex: Female