BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
Report
- Report Number
- 9610847-2018-00129
- Event Type
- Malfunction
- Date Received
- May 8, 2018
- Date of Event
- April 9, 2018
- Report Date
- August 23, 2018
- 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
- FI
- Reporter Occupation
- OTHER
Narratives
DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: DEVICE RETURNED TO MANUFACTURE:YES.
H.6. INVESTIGATION SUMMARY: DEVICE/BATCH HISTORY RECORD REVIEW FOR THE SUB ASSEMBLY LOT NUMBERS FOR MATERIAL #8001498. FINDINGS: 7220546 ¿ A TOTAL OF 180,000 UNITS WERE MANUFACTURED ON QFA LINE 2 STARTING ON 21AUG2017 THROUGH 23AUG2017. 7220545 ¿ A TOTAL OF 183,055 UNITS WERE MANUFACTURED ON QFA LINE 2 STARTING ON 19AUG2017 THROUGH 21AUG2017. 7220550 ¿ A TOTAL OF 180,000 UNITS WERE MANUFACTURED ON QFA LINE 3 STARTING ON 16AUG2017 THROUGH 18AUG2017. REVIEW OF THE DHRS REVEALED ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. PER REVIEW IT WAS NOTED THAT THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. THE PEURA (END USER RISK ANALYSIS) WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE. OBSERVATIONS AND TESTING: RECEIVED A PARTIAL Q-SYTE UNIT (TOP BODY ONLY) INSIDE AN OPEN PACKAGE FROM LOT NUMBER 7242777. VISUAL/MICROSCOPIC EXAMINATION: ONLY THE TOP BODY OF A Q-SYTE UNIT WAS RECEIVED TRACES OF MEDICINAL MATERIAL WAS OBSERVED. THE SEPTUM WAS MOLDED USING THE 16 CAVITY MOLD. DAMAGE (TEARS) ON THE SLIT OF THE SEPTUM TOP DISK WAS OBSERVED. OBSERVED THE RIM OF THE Q-SYTE BODY REVEALED ADEQUATE TRACES OF WELD, WHICH IS AN INDICATION THAT A BOND WAS PROVIDED DURING THE MANUFACTURING PROCESS. CONCLUSIONS: THE Q-SYTE TOP BODY HAD BEEN SEPARATED FROM THE Q-SYTE BOTTOM BODY AT THE WELD JOINT (ONLY THE TOP BODY WAS RECEIVED). THE RIM OF THE TOP BODY REVEALED ADEQUATE TRACES OF WELD. A DEFINITE SOURCE THAT CAUSED THE Q-SYTE UNIT TO SEPARATE AT THE WELD JOINT COULD NOT BE DETERMINED, THE RIM OF THE RETURNED PORTION REVEALED ADEQUATE TRACES OF WELD WHICH IS AN INDICATION THAT A BOND WAS PROVIDED DURING THE MANUFACTURING PROCESS. A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. A DEFINITE ROOT CAUSE THAT CAUSED THE DAMAGE OBSERVED WITH THE RETURNED UNIT COULD NOT BE IDENTIFIED. CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A MONTHLY BASIS. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME.
DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: DEVICE RETURNED TO MANUFACTURE:YES.
IT WAS REPORTED WITH THE USE OF THE BD Q-SYTE LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE THERE WAS AN ISSUE WITH LEAKAGE. IT WAS STATED ¿DURING FLUSHING THE IV Q-SYTE BROKE IN THE MIDDLE OF THE PRODUCT.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.
IT WAS REPORTED WITH THE USE OF THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE THERE WAS AN ISSUE WITH LEAKAGE. IT WAS STATED ¿DURING FLUSHING THE IV Q-SYTE BROKE IN THE MIDDLE OF THE PRODUCT.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.
IT WAS REPORTED WITH THE USE OF THE BD Q-SYTE LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE THERE WAS AN ISSUE WITH LEAKAGE. IT WAS STATED ¿DURING FLUSHING THE IV Q-SYTE BROKE IN THE MIDDLE OF THE PRODUCT.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED WITH THE USE OF THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE THERE WAS AN ISSUE WITH LEAKAGE. IT WAS STATED ¿DURING FLUSHING THE IV Q-SYTE BROKE IN THE MIDDLE OF THE PRODUCT.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 336171 | BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE | Q-SYTE | FPA | BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. | 7242777 | 30382903851004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |