BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE, BNS
Report
- Report Number
- 1710034-2018-00237
- Event Type
- Malfunction
- Date Received
- May 24, 2018
- Date of Event
- February 9, 2018
- Report Date
- December 17, 2018
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FPA
- PMA / PMN Number
- K013621
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
H.6. INVESTIGATION SUMMARY: DEVICE/BATCH HISTORY RECORD REVIEW 7094620 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 2, FROM APRIL 14, 2017 THRU APRIL 17, 2017 7100575 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 2, FROM APRIL 17, 2017 THRU APRIL 20, 2017 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 THREE UNUSED Q-SYTE UNITS ATTACHED TO EXTENSION SET WITH NEEDLE WITH A NOTE THAT STATED ¿Q-SYTE LOT 7094620¿. VISUAL/MICROSCOPIC EVALUATION: ALL SEPTA WERE MOLDED USING THE 16- CAVITY MOLD ¿ UNIT 1 ¿ SEPTUM LIFTS AT THE RIM OF THE TOP BODY. ¿ A SMALL SLIT TEAR ON THE SEPTUM TOP DISK. ¿ UNIT 2 ¿ A SMALL SLIT TEAR ON THE SEPTUM TOP DISK. ¿ UNIT 3 ¿ SLIT TEAR ON THE SEPTUM TOP DISK. FLUID LEAK TEST: ¿ THE MALE LUER OF A LAB SUPPLIED BD 10ML SYRINGE FILLED WITH RED FLUID WAS CONNECTED TO THE FEMALE LUER OF EACH Q-SYTE. ¿ PRESSURE WAS APPLIED TO THE PLUNGER OF THE SYRINGE TO ASSESS LEAKAGE AT THE Q-SYTE UNITS AND SYRINGE. ¿ LEAKAGE WAS NOT CONFIRMED ON ANY OF THE RETURNED Q-SYTE UNITS. WATER/AIR LEAK TEST: THE MALE SLIP LUER OF THE WATER/AIR LEAK TEST WAS INSERTED INTO THE SEPTUM OF THE Q-SYTE UNITS. NO AIR BUBBLES OBSERVED IN THE AREA OF THE Q-SYTE UNITS. SEPTUM COLUMN TEAR ASSESSMENT: NO DAMAGE (CUTS/TEARS) WAS OBSERVED ALONG THE COLUMN WALL ON ANY OF THE Q-SYTE UNITS. BOTTOM SEPTUM EVALUATION: THE RETURNED UNIT WAS DISASSEMBLED TO EVALUATE THE BOTTOM SEPTUM CONDITION. ¿ UNIT 1 ¿ NO PHYSICAL/MECHANICAL DAMAGE WAS OBSERVED TO THE SEPTUM BOTTOM DISK. ¿ UNIT 2 - A SMALL SLIT TEAR ON THE BOTTOM SEPTUM DISK ¿ UNIT 3 - A SMALL SLIT TEAR ON THE BOTTOM SEPTUM DISK THE SEPTUM SLIT CENTEREDNESS: ¿ THE SEPTUM SLIT CUT WAS NOT OFF CENTER ON ANY OF THE RETURNED Q-SYTE UNITS. ¿ CONCLUSIONS: THE DEFECT LEAKAGE, AS STATED AS THE REPORTED CODE WAS NOT CONFIRMED NOR REPLICATED WITH THE RETURNED UNITS. CONFIRMED THERE WERE SLIT TEAR ON THE SEPTUM TOP AND SEPTUM LIFTS UP FROM THE TOP BODY. CONFIRMED THERE WAS RESIDUAL SEPTUM AND ADHESIVE DEPOSITS ON THE RIM OF THE TOP BODY. THE EVALUATION OF THE SEPTUM UNGLUED/LIFTS UP AT RIM LOCATIONS REVEALED EVIDENCE OF RESIDUAL SEPTUM MATERIAL AND ADHESIVE DEPOSITS. THIS IS AN INDICATION THAT A BOND WAS PROVIDED DURING THE MANUFACTURING PROCESS. A DEFINITE SOURCE THAT CONTRIBUTED TO THE SLIT TEARS COULD NOT BE ESTABLISHED. AN INSTRUCTION PAMPHLET IS PROVIDED WITH Q-SYTE PRODUCT. THIS INFORMATION DOCUMENTS THE POTENTIAL FAILURE MODES OF THIS DEVICE IF NOT USED PROPERLY. A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. 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.
IN ADDITION, CUSTOMER SENT A VIDEO RECEIVED 07DEC2018. VIDEO INFORMATION SENT SEPARATELY TO THE SANDY PLANT QUALITY ENGINEER FOR FURTHER REVIEW. BASED ON THE REVIEW OF THE SUBMITTED VIDEO THE DEFECT OF LEAKAGE WAS CONFIRMED BASED ON THE AIR BUBBLES. AIR BUBBLES ARE INDICATIVE OF LEAKAGE. ALTHOUGH LEAKAGE WAS CONFIRMED BASED ON THE AIR BUBBLES OBSERVED IN THE VIDEO. THE SOURCE OF THE AIR BUBBLES IN UNKNOWN.
CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, 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 THAT LEAKAGE OCCURRED WHILE USING A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE, BNS. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
IT WAS REPORTED THAT LEAKAGE OCCURRED WHILE USING A BD Q-SYTE LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE, BNS. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
IT WAS REPORTED THAT LEAKAGE OCCURRED WHILE USING A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE, BNS. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
TWO POTENTIAL LOT NUMBERS WERE PROVIDED FOR THIS INCIDENT. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7094620, MEDICAL DEVICE EXPIRATION DATE: 2022-04-30, DEVICE MANUFACTURE DATE: 2017-04-04, MEDICAL DEVICE LOT #: 7100575, MEDICAL DEVICE EXPIRATION DATE: 2022-04-30, DEVICE MANUFACTURE DATE: 2017-04-10. (B)(6). 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 LEAKAGE OCCURRED WHILE USING A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE, BNS. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 382700 | BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE, BNS | Q-SYTE SPLIT SEPTUM | FPA | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | SEE H.10. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |