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 Date 05/08/2023

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 fell out of the patient [device issue].Placing a jada system with a speculum/ provider inserted it into the internal cervical os [wrong technique in device usage process].No additional ae reported [no adverse event].Case narrative: this spontaneous report originating from united states was received from an unspecified nursing staff via clinical educator (ce), referring to a non-pregnant female patient of unknown age.The patient's concurrent conditions, drug reactions/allergies and concomitant medications were not reported.Her medical history included vaginal delivery and pregnancy.This report concerns 1 patient and 1 device (suspected device).On 08-may-2023 (reported as couple of days ago), the patient was placed with vacuum-induced hemorrhage control system (jada system) via an unknown route (lot#, serial # and expiration date were not reported) for postpartum bleeding (postpartum haemorrhage) by the physician (reported as provider).It was reported that the provider placed the vacuum-induced hemorrhage control system (jada system) with a speculum (wrong technique in device usage process), filled the cervical seal, connected it to suction and the vacuum-induced hemorrhage control system (jada system) fell out of the patient (device issue).Speculum was removed prior to the vacuum-induced hemorrhage control system (jada system) falling out per clinical educator.Another provider was called to place the vacuum-induced hemorrhage control system (jada system) (presumably the second device) and that provider inserted it into the internal cervical orifice (os).(the ce was unsure if the second provider reinserted the same vacuum-induced hemorrhage control system (jada system), however, it was also reported that "more than one vacuum-induced hemorrhage control system (jada system) devices were used"; discrepancy).Per the second provider "that was how he always placed them".Per clinical educator the second vacuum-induced hemorrhage control system (jada system) worked well for the second insertion.It was also reported that the patient sought medical attention, and it wasn't the operators' first time using the vacuum-induced hemorrhage control system (jada system).Limited amount of information was provided.It was also reported that treatment with vacuum-induced hemorrhage control system (jada system) was discontinued.No additional adverse event (ae) (no adverse event) was reported.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.Upon internal review, the event "device issue" was considered as serious as it required intervention.Medical device reporting criteria: serious injury.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.Fda code (health effects-health impact per annex f): 4648 insufficient information (there is not yet enough information available to classify the health impact).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: 16962049
• MDR Text Key: 315561372
• Report Number: 3002806821-2023-00058
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/19/2023

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?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/19/2023
• 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): Required Intervention
• Patient Sex: Female