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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORGANON & CO. JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM
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ORGANON & CO. JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM Back to Search Results
Lot Number 1070335
Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
Visual inspection was performed on the complaint sample and defect observed.Investigation of the event by the manufacturing site is ongoing.A follow up report will be submitted with the conclusion of the investigation.
 
Event Description
When she added saline to it, it was not inflating and when she tried to troubleshoot, she could see a slit in the balloon [device breakage].Case narrative: this initial spontaneous report originating from the united states was received from a healthcare professional via designated point of contact (dpoc) and company representative, referring to a patient of unknown age and gender.The patient's medical history, concurrent conditions, past drugs, allergies and concomitant medications were not reported.This report concerned 1 patient and 1 device.On an unknown date, the patient was inserted with vacuum-induced hemorrhage control system (jada system) via an unknown route (lot # 1070335 and expiry date was reported as 01-jun-2025; serial # was not reported) by the provider (healthcare professional) for an unknown indication.The provider stated that when she added saline to the device, it was not inflating and when she tried to troubleshoot, she could see a slit in the balloon (device breakage, onset date: unknown).Reportedly, the device was used on the patient.No additional adverse event (ae)/product quality complaint (pqc) was reported.The defective vacuum-induced hemorrhage control system (jada system) was available with the provider, however, it was covered in blood and stored in a red biohazard bag.Therefore, no pictures could be provided.Upon internal review, the event of device breakage was determined to be medically significant.Fda code: (health effects - health impact per annex f): 4648 insufficient information (there is not yet enough information available to classify the health impact).This is one of the two reports received from the same reporter.
 
Manufacturer Narrative
Visual inspection was performed on the complaint sample and defect observed.Investigation of the event by the manufacturing site is ongoing.A follow up report will be submitted with the conclusion of the investigation.
 
Event Description
When she added saline to it, it was not inflating and when she tried to troubleshoot, she could see a slit in the balloon [device breakage] case narrative: this initial spontaneous report originating from the united states was received from a healthcare professional via designated point of contact (dpoc) and company representative, referring to a patient of unknown age and gender.The patient's medical history, concurrent conditions, past drugs, allergies and concomitant medications were not reported.This report concerned 1 patient and 1 device.On an unknown date, the patient was inserted with vacuum-induced hemorrhage control system (jada system) via an unknown route (lot # 1070335 and expiry date was reported as 01-jun-2025; serial # was not reported) by the provider (healthcare professional) for an unknown indication.The provider stated that when she added saline to the device, it was not inflating and when she tried to troubleshoot, she could see a slit in the balloon (device breakage, onset date: unknown).Reportedly, the device was used on the patient.No additional adverse event (ae)/product quality complaint (pqc) was reported.The defective vacuum-induced hemorrhage control system (jada system) was available with the provider, however, it was covered in blood and stored in a red biohazard bag.Therefore, no pictures could be provided.Upon internal review, the event of device breakage was determined to be medically significant.Fda code: (health effects - health impact per annex f): 4648 insufficient information (there is not yet enough information available to classify the health impact).This is one of the two reports received from the same reporter.
 
Manufacturer Narrative
Visual inspection was performed on the complaint sample and defect observed.There is currently no indication that a nonconforming device was manufactured.The root cause cannot be determined being the device was used and there are no indications that the device was released as nonconforming.
 
Event Description
When she added saline to it, it was not inflating and when she tried to troubleshoot, she could see a slit in the balloon/the balloon defect of "pinhole" was verified.[device breakage] case narrative: this initial spontaneous report originating from the united states was received from a healthcare professional via designated point of contact (dpoc) and company representative, referring to a patient of unknown age and gender.The patient's medical history, concurrent conditions, past drugs, allergies and concomitant medications were not reported.This report concerned 1 patient and 1 device.On an unknown date, the patient was inserted with vacuum-induced hemorrhage control system (jada system) via an unknown route (lot # 1070335 and expiry date was reported as (b)(6) 2025; serial # was not reported) by the provider (healthcare professional) for an unknown indication.The provider stated that when she added saline to the device, it was not inflating and when she tried to troubleshoot, she could see a slit in the balloon (device breakage, onset date: unknown).Reportedly, the device was used on the patient.No additional adverse event (ae)/product quality complaint (pqc) was reported.The defective vacuum-induced hemorrhage control system (jada system) was available with the provider, however, it was covered in blood and stored in a red biohazard bag.Therefore, no pictures could be provided.Upon internal review, the event of device breakage was determined to be medically significant.Fda code: (health effects - health impact per annex f): 4648 insufficient information (there is not yet enough information available to classify the health impact).This is one of the two reports received from the same reporter.Follow-up information received on (b)(6) 2023.It was reported that one complaint sample was available for inspection at the location where the event occurred.From the evidence provided, the balloon defect of ¿pinhole¿ was verified.The investigation had been completed, and based on the updated information received, there is currently no indication that a nonconforming device was manufactured.Device history records, deviations, incoming inspection, and capa reviews were performed with no non-conformances noted.The device is assembled per specifications where in-process and final inspections are conducted by trained personnel.During assembly balloons are inflated with 220ml of air, submerged in 99% alcohol and checked for leaks and bubbles along the balloon.Operations would have observed this type of defect during in-process testing.Any units failing this 100% verification are discarded.The root cause cannot be determined being the device was used and there are no indications that the device was released as nonconforming.
 
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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 Key17143594
MDR Text Key317343907
Report Number3002806821-2023-00071
Device Sequence Number1
Product Code OQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
510K K201199
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 11/29/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number1070335
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/02/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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