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

Lot Number UNKNOWN

Device Problems Leak/Splash (1354); Mechanical Problem (1384)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Lot number has not been identified for this complaint.(currently identified as unknown) investigation of the event by the manufacturing site is ongoing.

Event Description

Jada seal was leaking and provider had to use another jada that worked correctly.[device leakage].No additional ae reported [no adverse event].Case narrative: this spontaneous report originating from united states was received from an other health professional via clinical account specialist referring to a female patient of unknown age.The patient's current conditions, concomitant medication, medical history, and past drug reactions/allergies were not reported.This report concerns 1 patient and 1 device.On an unknown date, the patient was placed with vacuum-induced hemorrhage control system (jada system) via intravaginal route (lot and expiration date were not reported) for postpartum hemorrhage.On an unknown date, clinical account specialist reported that vacuum-induced hemorrhage control system (jada system) seal was leaking (device leakage) and provider had to use another vacuum-induced hemorrhage control system (jada system) that worked correctly.The patient sought medical attention.No additional adverse event (ae) (no adverse event) reported.Upon internal review, the event device leakage was determined to be serious due required intervention (devices).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: malfunction.

Event Description

Jada seal was leaking and provider had to use another jada that worked correctly.[device leakage].No additional ae reported [no adverse event].Case narrative: this spontaneous report originating from united states was received from an other health professional via clinical account specialist referring to a non-pregnant female patient of unknown age.The patient's current conditions, concomitant medication, medical history, and past drug reactions/allergies were not reported.This report concerns 1 patient and 1 device.On an unknown date, the patient was placed with vacuum-induced hemorrhage control system (jada system) via intravaginal route (lot and expiration date were not reported) for postpartum hemorrhage.On an unknown date, clinical account specialist reported that vacuum-induced hemorrhage control system (jada system) seal was leaking (device leakage) and provider had to use another vacuum-induced hemorrhage control system (jada system) that worked correctly.The patient sought medical attention.No additional adverse event (ae) (no adverse event) reported.Upon internal review, the event device leakage was determined to be serious due required intervention (devices).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: malfunction.Follow up information received from other health professional on 30-apr-2024.Other health professional stated that the cause of the leak in the vacuum-induced hemorrhage control system (jada system) was a pin hole.

Manufacturer Narrative

Lot number has not been identified for this complaint.(currently identified as unknown) investigation of the event by the manufacturing site is ongoing.

Manufacturer Narrative

Lot number has not been identified for this complaint.(currently identified as unknown) investigation of the event by the manufacturing site is ongoing.

Event Description

Jada seal was leaking and provider had to use another jada that worked correctly.[device leakage].No additional ae reported [no adverse event].Case narrative: this spontaneous report originating from united states was received from an other health professional via clinical account specialist referring to a non-pregnant female patient of unknown age.The patient's current conditions, concomitant medication, medical history, and past drug reactions/allergies were not reported.This report concerns 1 patient and 1 device.On an unknown date, the patient was placed with vacuum-induced hemorrhage control system (jada system) via intravaginal route (lot and expiration date were not reported) for postpartum hemorrhage.On an unknown date, clinical account specialist reported that vacuum-induced hemorrhage control system (jada system) seal was leaking (device leakage) and provider had to use another vacuum-induced hemorrhage control system (jada system) that worked correctly.The patient sought medical attention.No additional adverse event (ae) (no adverse event) reported.Upon internal review, the event device leakage was determined to be serious due required intervention (devices).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: malfunction.Follow up information received from other health professional on 30-apr-2024.Other health professional stated that the cause of the leak in the vacuum-induced hemorrhage control system (jada system) was a pin hole.Follow up information received from a nurse on 13-may-2024.The patient's medical history included vaginal delivery.The patient's current condition included uterine atony.The patient delivered child vaginally and went home, then came back to their facility a couple days later due to delayed post-partum hemorrhage.The nurse reported that a second vacuum-induced hemorrhage control system (jada system) was used without issue after the first device leaked.The healthcare professional stated that the leak was due to a pin hole.The nurse reported that they also administered oxytocin (pitocin) to the patient and thought the cause of the postpartum hemorrhage was uterine atony.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: malfunction.

• 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: 19202895
• MDR Text Key: 341283949
• Report Number: 3002806821-2024-00039
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/16/2024

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: UNKNOWN
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/07/2024; 05/16/2024
• 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