BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE
Report
- Report Number
- 9610847-2018-00135
- Event Type
- Malfunction
- Date Received
- May 22, 2018
- Date of Event
- April 27, 2018
- Report Date
- July 11, 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
- CH
- Reporter Occupation
- OTHER
Narratives
INVESTIGATION SUMMARY: DEVICE/BATCH HISTORY RECORD REVIEW: DHR REVIEW WAS PERFORMED ON THE FOLLOWING SUB ASSEMBLY LOT NUMBERS: 7143620 THIS LOT NUMBER WAS BUILT ON QFA LINE 3 FROM JUNE 1, 2017 THRU JUNE 3, 2017. 7143622 THIS LOT NUMBER WAS BUILT ON QFA LINE 3 FROM JUNE 5, 2017 THRU JUNE 7, 2017 7152682 THIS LOT NUMBER WAS BUILT ON QFA LINE 2 FROM JUNE 23, 2017 THRU JUNE 25, 2017. 7152691 THIS LOT NUMBER WAS BUILT ON QFA LINE 3 FROM JUNE 14, 2017 THRU JUNE 16, 2017. 7160875 THIS LOT NUMBER WAS BUILT ON QFA LINE 2 FROM JUNE 25, 2017 THRU JUNE 27, 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 ONE USED Q-SYTE UNIT IN AN OPENED PACKAGE FROM THE LOT NUMBER 7178870. VISUAL/MICROSCOPIC EXAMINATION: THE SEPTUM WAS MOLDED USING THE 16-CAVITY MOLD. NO PHYSICAL/MECHANICAL DAMAGE WAS OBSERVED ON ANY OF THE EXTERNAL AREAS OF THE Q-SYTE UNIT. WATER LEAK TEST: Q-SYTE WAS LEAK TESTED IN THE ACTUATED AND UN-ACTUATED POSITIONS; LEAKAGE WAS NOT CONFIRMED IN THE ACTUATED OR UN-ACTUATED POSITIONS. SEPTUM COLUMN TEAR ASSESSMENT: DAMAGE (TEAR) OBSERVED ALONG THE COLUMN WALL. BOTTOM SEPTUM EVALUATION: THE RETURNED UNIT WAS DISASSEMBLED TO EVALUATE THE BOTTOM SEPTUM CONDITION. OBSERVED SLIT TEARS ON THE SEPTUM BOTTOM DISK. A PHOTO TAKEN TO EVALUATE THE SLIT CENTEREDNESS SHOWED THE SEPTUM SLIT CUT WAS NOT OFF CENTER. THE RETURNED Q-SYTE UNIT PROVIDED FOR EVALUATION DISPLAYED SEPTUM SLIT TEAR AND COLUMN TEAR. ALTHOUGH LEAKAGE WAS NOT CONFIRMED, THE PRESENCE OF THE COLUMN TEAR IS INDICATIVE OF LEAKAGE. CONFIRMED THERE WERE SLITS TEARS ON THE SEPTUM BOTTOM DISK AND A COLUMN TEAR. A DEFINITE SOURCE THAT CAUSED DAMAGE TO THE COLUMN TEAR; WHICH COULD HAVE CONTRIBUTED TO THE LEAKAGE, COULD NOT BE ESTABLISHED. THE FAILURE MODES NORMALLY ATTRIBUTED TO THESE TYPES OF DAMAGE ARE INCORRECT USAGE OR EXCESSIVE ACTUATIONS. A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. A MANUFACTURING RELATED ROOT CAUSE 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.
IT WAS REPORTED THAT A NURSE FOUND LEAKAGE ON A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE WHILE CONNECTING TO THE INFUSION SET. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR 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 THAT A NURSE FOUND LEAKAGE ON A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE WHILE CONNECTING TO THE INFUSION SET. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 377718 | BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE | LUER ACCESS SPLIT SEPTUM | FPA | BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. | 7178870 | 30382903851004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |