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

1 jada failed [device ineffective].Case narrative: this initial spontaneous report originating from the united states, was received from a clinical account specialist (cas) referring to a non-pregnant female patient of unknown age.The patient's concurrent conditions, medical history, past drugs/ allergies and concomitant medications were not reported.This report concerns 1 patient and 1 device.On an unknown date, a health care professional placed vacuum-induced hemorrhage control system (jada system) (route, lot# and expiration date were not reported) for an unknown indication.Per cas six vacuum-induced hemorrhage control system (jada system) were on trial to facility, five of the vacuum-induced hemorrhage control system (jada system) worked and one failed (device ineffective, onset date: unknown).Cas stated that there was no provider or patient information.No additional adverse event (ae) or product quality complaint (pqc) was reported.Upon internal review, the event of device ineffective was considered medically significant.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): 4648 insufficient information (there is not yet enough information available to classify the health impact).

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.

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

1 jada failed [device ineffective].User error issue [device use error].Case narrative: this initial spontaneous report originating from the united states, was received from a clinical account specialist (cas) referring to a non-pregnant female patient of unknown age.The patient's concurrent conditions, medical history, past drugs/ allergies and concomitant medications were not reported.This report concerns 1 patient and 1 device.On an unknown date, a health care professional placed vacuum-induced hemorrhage control system (jada system) (route, lot# and expiration date were not reported) for an unknown indication.Per cas six vacuum-induced hemorrhage control system (jada system) were on trial to facility, five of the vacuum-induced hemorrhage control system (jada system) worked and one failed (device ineffective, onset date: unknown).Cas stated that there was no provider or patient information.No additional adverse event (ae) or product quality complaint (pqc) was reported.Upon internal review, the event of device ineffective was considered medically significant.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): 4648 insufficient information (there is not yet enough information available to classify the health impact).Follow up information was received from an unspecified manager via cas on 10-may-2023.The manager was updated as the primary reporter.The manager stated that it was user error issue (further unspecified) (device use error, onset date: unknown) and then they opened a new one and used it without difficulty.

• 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: 16920034
• MDR Text Key: 315103063
• Report Number: 3002806821-2023-00055
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• 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