JADA SYSTEM
Report
- Report Number
- 3002806821-2023-00071
- Event Type
- Malfunction
- Date Received
- June 16, 2023
- Report Date
- November 29, 2023
- Manufacturer
- ORGANON & CO.
- Product Code
- OQY
- PMA / PMN Number
- 510K K201199
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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.
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.
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.
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.
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.
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2187973 | JADA SYSTEM | INTRAUTERINE VACUUM CONTRACTION SYSTEM | OQY | ORGANON & CO. | 1070335 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |