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

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

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

Event Date 08/01/2022

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

Jada system was discontinued because they thought is wasn't working properly [device ineffective].There was bleeding around the cervical seal [device leakage].Per nurse jada system was not suctioning [device issue].I think it was a placement issue [device placement issue].Case narrative: this spontaneous report originating from united states as received from registered nurse (from a nursing staff undergoing in-service) via clinical educator, referring to a female patient of unknown age.The patient's concurrent conditions and drug reactions / allergies were not reported.The patient's medical history included pregnancy and delivery.The patient's concomitant medications included unspecified uterotonic drug.There was no maternal admission to intensive care unit (icu).This report concerned 1 patient and 1 device.On an unknown date in august 2022, the patient underwent vacuum-induced hemorrhage control system (jada system) (1.0) placement via vaginal route (lot# and expiration date were not reported for postpartum bleeding (postpartum hemorrhage).After placement, the same day of insertion at unknown time, there was a bleeding around the cervical seal (device leakage) and was disconnected and the vacuum-induced hemorrhage control system (jada system) was not suctioning according to nurse (device issue).The reporting nurse was unsure if it was inflated enough or how much fluid was used.The vacuum-induced hemorrhage control system (jada system) was discontinued (removed) as it was not working properly and did not stop control the bleeding (device ineffective), and another unspecified uterine tonic was used.The vacuum-induced hemorrhage control system (jada system) did not break (the plastic breaks apart) nor it was difficult to connect or lost connection.It was reported that the patient sought medical attention.The reporter reported that she did not think it was a quality issue and thought it was a placement issue (device placement issue).The clinical educator was unable to obtain any additional information.No additional adverse event (ae)/ product quality complaint (pqc) reported.No additional information provided.No further information provided.For vacuum-induced hemorrhage control system (jada system), the lot number and the serial number was not available.Upon internal review, device ineffective was determined to be medically significant.Medical device reporting criteria: 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).

• 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: 16064200
• MDR Text Key: 306316905
• Report Number: 3002806821-2022-00033
• 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: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• 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