BD Q-SYTE LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
Report
- Report Number
- 9610847-2020-00056
- Event Type
- Malfunction
- Date Received
- February 24, 2020
- Date of Event
- February 3, 2020
- Report Date
- April 20, 2020
- Manufacturer
- BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
- Product Code
- FPA
- UDI-DI
- 30382903851004
- PMA / PMN Number
- K013621
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- NURSE
Narratives
H.6. INVESTIGATION SUMMARY A PHYSICAL SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BUT BD WAS PROVIDED WITH 2 PHOTOS OF THE DEFECT FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT, 9031825, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTOS AND OBSERVED DAMAGE TO THE Q-SYTE. THE FIRST PHOTO SHOWED THE TOP BODY AND THE SECOND PHOTO SHOWED THE BOTTOM PORTION OF THE BODY. THIS INDICATED THAT THERE WAS SEPARATION OF THE SEPTUM. NO OTHER DAMAGE WAS VISIBLE. BASED OFF THE PROVIDED PHOTOS THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. UNFORTUNATELY, WITHOUT A PHYSICAL SAMPLE AVAILABLE FOR INVESTIGATION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
IT WAS REPORTED THAT THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE WAS FOUND DAMAGED DURING USE. THE DEVICE WAS USED ON THE END OF A DUAL-CAVITY CVC, AND WHEN ATTEMPTING TO DISCONNECT IT AFTER THREE DAYS OF USE, THE JOINT CONNECTION WAS FOUND BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "THIS CONNECTOR WAS USED ON ONE END OF THE DUAL-CAVITY CVC OF THE ARRIVE BRAND. AFTER 3 DAYS OF USAGE, WHEN THE NURSE TEACHER REPLACED THE Q-SYTE AT NOON, THEY ROUTINELY UNSCREWED THE Q-SYTE AND FOUND THAT PART OF THE JOINT LIQUID PATH CONNECTING THE CVC CATHETER END WAS BROKEN AT THE CVC CATHETER END, WHICH LED TO THE FAILURE OF NORMAL USE OF THIS PATH. AT PRESENT, THE CVC PIPELINE WAS STILL IN THE PATIENT'S BODY. THE MEDICAL STAFF IS TRYING TO REMOVE THE BROKEN END OF THE JOINT AND USE THE OTHER END OF CVC FOR INFUSION TREATMENT."
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE WAS FOUND DAMAGED DURING USE. THE DEVICE WAS USED ON THE END OF A DUAL-CAVITY CVC, AND WHEN ATTEMPTING TO DISCONNECT IT AFTER THREE DAYS OF USE, THE JOINT CONNECTION WAS FOUND BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "THIS CONNECTOR WAS USED ON ONE END OF THE DUAL-CAVITY CVC OF THE ARRIVE BRAND. AFTER 3 DAYS OF USAGE, WHEN THE NURSE TEACHER REPLACED THE Q-SYTE AT NOON, THEY ROUTINELY UNSCREWED THE Q-SYTE AND FOUND THAT PART OF THE JOINT LIQUID PATH CONNECTING THE CVC CATHETER END WAS BROKEN AT THE CVC CATHETER END, WHICH LED TO THE FAILURE OF NORMAL USE OF THIS PATH. AT PRESENT, THE CVC PIPELINE WAS STILL IN THE PATIENT'S BODY. THE MEDICAL STAFF IS TRYING TO REMOVE THE BROKEN END OF THE JOINT AND USE THE OTHER END OF CVC FOR INFUSION TREATMENT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 211640 | BD Q-SYTE LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE | INTRAVASCULAR ADMINISTRATION SET | FPA | BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. | 385100 | 9031825 | 30382903851004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |