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  

Event Description

It was clogged up with clots and another physician came in to place the 2nd jada system [device occlusion] she didn¿t think the patient was dilated 3cm, but she said the physician said the patient was dilated 3cm".[wrong technique in device usage process] case narrative: this initial spontaneous report originating from the united states, was received from a company representative via nurse, referring to a female patient of unknown age.The patient¿s current conditions, medical history and concomitant medications were not reported.This report concerns 1 patient and 2 devices.On an unknown date, the patient was started on vacuum-induced hemorrhage control system (jada system #1) (lot# and expiry date were not reported) for unknown indication (product used for unknown indication).It was told by the nurse stated that it was clogged up with clots (device occlusion) and another physician came in to place the second vacuum-induced hemorrhage control system (jada system # 2) (lot# and expiry date were not reported) for unknown indication (product used for unknown indication).The patient did well with the second vacuum-induced hemorrhage control system (jada system # 2) in place (required intervention).The nurse also stated the physician said the patient was dilated 3 centimeters (cm) but she did not think the patient was dilated 3cm (wrong technique in device usage process).The nurse also said the event was not "an adverse event" but "more like user error".The availability of the vacuum-induced hemorrhage control system (jada system) for evaluation was unknown.Upon internal review, the event of "device occlusion" was determined to be serious: required intervention.Medical device reporting criteria: serious injury.(b)(4).

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.

• 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: 16014976
• MDR Text Key: 305818843
• Report Number: 3002806821-2022-00026
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• 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): Required Intervention
• Patient Sex: Female