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

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

Does not know if the loop was displaced or got pushed further up in the cervix/had issues placing it [device placement issue].The uterus was filling with blood and the jada was removed / not work but it did not achieve a seal [device ineffective].Case narrative: this spontaneous report was received from a registered nurse via clinical account specialist (cas) referring to a female patient of unknown age.The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions/allergies were not reported.This report concerns 1 patient and 1 device.On an unknown date, the vacuum-induced hemorrhage control system (jada system) was used by the physician in the operating room on patient for an unknown indication (product used for unknown indication) but there was issue placing it (device placement issue) (route of administration, lot#, expiration date were not reported).No further information was provided.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.Upon internal review, the event device placement issue was determined to be medically significant.Medical device reporting criteria: 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).Follow-up information was received from the physician via clinical account specialist (cas) on 09-dec-2022.The patient's medical history included pregnancy and had caesarean section (c-section) for delivery.The vacuum-induced hemorrhage control system (jada system) was placed, and the uterine incision was still open and could see the loop was in the appropriate place.It was reported that hysterotomy was sewed up.The nurse filled the cervical seal with 60 milliliters (ml) of sterile fluid and not maximum of 120 cubic centimeter (cc) and that point the provider does not know if the loop was displaced or got pushed further up in the cervix which made it not work but it did not achieve a seal.The provider could see that the uterus was filled with blood (device ineffective) and the vacuum-induced hemorrhage control system (jada system) was removed, and it was unknown what was used after the vacuum-induced hemorrhage control system (jada system) was removed.No further information provided.Upon internal review, the event device ineffective was considered to be medically significant.Medical device reporting criteria: serious injury.Fda code: (b)(4).

• 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: 16029042
• MDR Text Key: 305978282
• Report Number: 3002806821-2022-00029
• 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
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female