BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
Report
- Report Number
- 9610847-2018-00193
- Event Type
- Injury
- Date Received
- June 29, 2018
- Date of Event
- June 11, 2018
- Report Date
- August 15, 2018
- Manufacturer
- BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
- Product Code
- FOZ
- UDI-DI
- 00382903833238
- PMA / PMN Number
- K013800
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
EVENT DESCRIPTION:FROM: IT WAS REPORTED THAT BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM HAD THE FOLLOWING ISSUE,"THE SAFETY MECHANISM FAILED AND EXPOSED THE NEEDLE MADE CONTACT WITH THE TECH FACE". NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED. EVENT DESCRIPTION: IT WAS REPORTED THAT BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM HAD THE FOLLOWING ISSUE,"THE SAFETY MECHANISM FAILED AND EXPOSED THE NEEDLE MADE CONTACT WITH THE TECH FACE". THE TECH WAS EXPOSED TO THE NEEDLE DURING USE. EXPOSURE TO MUCOUS, BLOOD /BODILY FLUIDS. NO REPORTS OF MEDICAL INTERVENTION NOTED. (B)(4).
DEVICE RETURNED TO MANUFACTURER: YES.
THE DEVICE HISTORY REPORT FOR LOT NUMBER 6277683 WAS REVIEWED, NO RELATED ABNORMALITIES WERE FOUND. MATERIAL NUMBER (B)(4) FOR LOT 6277683 WAS MANUFACTURED ON 10/12/2016. THIS IS THE FIRST INSTANCE OF THIS FAILURE MODE WITH THIS LOT NUMBER. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED, WITH NO DEFECTS BEING NOTED DURING FINAL ASSEMBLY OR IN PACKAGING VISUAL INSPECTIONS. ADDITIONALLY REPRESENTATIVE SAMPLES WERE PROVIDED FOR THE PURPOSE OF AIDING OUR QUALITY ENGINEER'S INVESTIGATION, ALL AVAILABLE UNITS WERE SUBJECTED TO PULL TESTING AND FOUND TO BE WITHIN PRODUCT SPECIFICATION. WITHOUT THE ABILITY TO OBSERVE OR DUPLICATE THE REPORTED ISSUE OUR INVESTIGATORS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. THE REPORTED SAFETY SHIELD ACTIVATION FAILURE BY CUSTOMER WAS NOT CONFIRMED AFTER EVALUATE THE REPRESENTATIVE SAMPLES RECEIVED. 6 REPRESENTATIVE SAMPLES MET THE ACCEPTANCE CRITERIA ACCORDING SI-16SP. NO VALUES OUT OF SPECIFICATION, PROBLEMS DURING ACTIVATION OR EXPOSED CANNULA WERE FOUND. THIS REPORTED DEFECT COULD BE RELATED WITH AN INCORRECT ACTIVATION DEVICE BY THE USER; SINCE, INSTRUCTION SHEET D12556 (FIGURE 3 AND 4), SHOW CORRECT WAY TO PERFORM THIS ACTIVATION. ALWAYS REFER TO IFU FOR PRODUCT USAGE RECOMMENDATIONS. WE WILL KEEP MONITORING THE MANUFACTURING PROCESS AND IN CASE ANY EMERGING TREND IS DETECTED, FURTHER ACTIONS WILL BE TAKEN IF NECESSARY. NO CORRECTIVE ACTION REQUIRED AT THE FAILURE. PROCESS (B)(4) WAS REVIEWED AND THERE ARE PROPER CONTROLS IN PLACE TO DETECT PRODUCT MALFUNCTIONS. BASED ON INVESTIGATION RESULTS TO DATE, THE ROOT CAUSE COULD BE RELATED WITH LACK OF TRAINING IN THE USE OF THE PRODUCT. NO CORRECTIVE ACTION WAS PERFORMED SINCE THIS ISSUE COULD NOT BE CONFIRMED AS MANUFACTURING RELATED.
IT WAS REPORTED THAT BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM HAD THE FOLLOWING ISSUE,"THE SAFETY MECHANISM FAILED AND EXPOSED THE NEEDLE MADE CONTACT WITH THE TECH FACE". THE TECH WAS EXPOSED TO THE NEEDLE DURING USE. EXPOSURE TO MUCOUS, BLOOD /BODILY FLUIDS. NO REPORTS OF MEDICAL INTERVENTION NOTED.
IT WAS REPORTED THAT BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM HAD THE FOLLOWING ISSUE,"THE SAFETY MECHANISM FAILED AND EXPOSED THE NEEDLE MADE CONTACT WITH THE TECH FACE". THE TECH WAS EXPOSED TO THE NEEDLE DURING USE. EXPOSURE TO MUCOUS, BLOOD /BODILY FLUIDS. NO REPORTS OF MEDICAL INTERVENTION NOTED.
IT WAS REPORTED THAT BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM HAD THE FOLLOWING ISSUE,"THE SAFETY MECHANISM FAILED AND EXPOSED THE NEEDLE MADE CONTACT WITH THE TECH FACE". NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.
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 BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM HAD THE FOLLOWING ISSUE,"THE SAFETY MECHANISM FAILED AND EXPOSED THE NEEDLE MADE CONTACT WITH THE TECH FACE". NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 492194 | BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM | INTRAVASCULAR CATHETER | FOZ | BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. | 6277683 | 00382903833238 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |