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 Hemorrhage/Bleeding (1888)

Event Date 08/07/2023

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

Blood leaking around the seal [device ineffective], he felt he did not place the device correctly [device placement issue], jada was placed with 125 ml saline in seal [wrong technique in device usage process].Case narrative: this spontaneous report originating from united states was received from a healthcare professional via clinical account specialist (cas), referring to a non-pregnant female patient of unknown age.The patient¿s current condition included uterine atony, gravida 2 and para 1.The patient¿s historical condition included pregnancy and caesarean section.This report concerned 1 patient and 1 device.After caesarean section (also reported as post operative), the patient was bleeding for one hour.On (b)(6) 2023, the patient was inserted with vacuum-induced hemorrhage control system (jada system) with 125 milliliter (ml) saline in seal (wrong technique in device usage process) via intravaginal route for postpartum haemorrhage.The provider states he did not placed the device correctly (device placement issue) but then noted blood leaking around the seal (device ineffective).The therapy with vacuum-induced hemorrhage control system (jada system) (device number 1) was discontinued and the provider then replaced with vacuum-induced hemorrhage control system (jada system) (device number 2).On (b)(6) 2023 (reported as prior to vacuum-induced hemorrhage control system (jada system) (device 2) insertion), ultrasound was performed and blood clots in the uterus were noted.It was reported ultrasound was not performed during vacuum-induced hemorrhage control system (jada system) use.The patient received unknown uterotonics.The patient sought medical attention.It was the provider's first time using the vacuum-induced hemorrhage control system (jada system).No product quality compliant (pqc) was reported.The availability of vacuum-induced hemorrhage control system (jada system) (device number 1) was unknown.For vacuum-induced hemorrhage control system (jada system) (device number 1) lot number and serial number were not provided.Upon internal review, the event of device ineffective was determined to be medically significant.This was one of the two reports received from the same reporter referring to same patient.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: serious injury.Fda code: (health effects - health impact per annex f): 4642 (use of an additional or alternative device require to achieve optimal outcome.).Fda code: (health effects - health impact per annex f): 4624 (one or more surgical procedures was required, or an existing procedure changed.).Fda code: (health effects - health impact per annex f): 4643 (patient required an infusion of whole blood or a blood component directly into the bloodstream.).

• 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: 17542101
• MDR Text Key: 321192090
• Report Number: 3002806821-2023-00099
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 08/14/2023

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?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2023
• 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): Other
• Patient Sex: Female