22G X 1.00IN (0.9 X 25 MM) INSYTE AUTOGUARD
Report
- Report Number
- 1710034-2019-01023
- Event Type
- Malfunction
- Date Received
- September 19, 2019
- Date of Event
- September 3, 2019
- Report Date
- October 16, 2019
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 30382903814238
- PMA / PMN Number
- K952861
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
H.6. INVESTIGATION SUMMARY: RECEIVED A 22GA CATHETER-ADAPTER ASSEMBLY WITHIN AN OPEN PACKAGE FROM LOT NUMBER 9164647. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT. VISUAL EXAMINATION: TRACES OF PATIENT RESIDUE WAS PRESENT ON THE CATHETER TUBING NO EVIDENCE OF DAMAGE COULD BE FOUND ON ANY OF THE COMPONENTS OF THE UNIT THEREFORE PROCEEDED TO WATER LEAK TEST. WATER-LEAK TEST: THE UNIT WAS TESTED BY CONNECTING THE END OF THE ADAPTER INTO THE ISO STANDARD WATER TEST FIXTURE, AIR BUBBLES WERE OBSERVED ABOVE THE NOSE OF THE ADAPTER. MICROSCOPIC EXAMINATION: THE TUBING-WEDGE ASSEMBLY WAS DISSECTED OUT OF THE ADAPTER, THE TUBING WAS WRINKLED ABOVE THE WEDGE, THE SOURCE OF THE LEAKAGE WAS CONFIRMED TO BE A CUT CAUSED BY THE WRINKLES ON THE TUBING. CONCLUSION(S): MANUFACTURING: THE WRINKLED TUBING CAN RESULT FROM: MISALIGNMENT OF THE FLARE STATION. WHEN THE FLARE STATION ISN¿T PROPERLY ALIGNED, IT CAN PULL THE TUBE DOWN ONTO THE SWAGE PIN CAUSING A HOLE IN THE TUBING ABOVE THE WEDGE. THE FLARE BLOCKS BEING WORN DOWN FROM REGULAR WEAR AND TEAR DURING THE MANUFACTURING PROCESS; THIS RESULTS IN TEARS TO THE TUBING. PRODUCT QUALITY IS EVALUATED DURING THE MANUFACTURING PROCESS WITH PRESCRIBED VARIABLE AND ATTRIBUTES INSPECTIONS. THESE INSPECTIONS ARE PERFORMED BY OPERATORS TO ENSURE PROCESS CHANGES ARE IDENTIFIED. IF DEFECTS ARE OBSERVED, DISPOSITION OF THE PRODUCT, ROOT CAUSE AND CORRECTIVE ACTION ARE APPLIED ACCORDING TO THE QUALITY CONTROL PLAN. VISUAL (PASS-FAIL) ¿ FLARE DAMAGE (WRINKLED OR SPLIT TUBING) IS PERFORMED AS PART OF ZONE 1 ATTRIBUTES SAMPLE PLAN PER S-AU8.
IT HAS BEEN REPORTED THAT ONE 22G X 1.00IN (0.9 X 25 MM) INSYTE AUTOGUARD HAS BEEN FOUND WITH A HOLE IN THE CATHETER DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT DURING IV PLACEMENT, BLOOD BEGAN TO LEAK FROM A HOLE IN THE CATHETER NEAR THE HUB. 2ND OCCURRENCE ((B)(6) 19): LOT# 9163647: RN WAS PLACING IV, ONCE THE IV WAS IN THE VEIN BLOOD WAS LEAKING FROM THE CATHETER NEAR THE HUB. IT WAS NOTICED THAT A HOLE WAS FOUND IN THE CATHETER. NO ONE WAS EXPOSED TO BLOOD (PPE WAS BEING WORN BY RN). CONTAMINATED SAMPLE IS AVAILABLE FOR INVESTIGATION.
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT HAS BEEN REPORTED THAT ONE 22G X 1.00IN (0.9 X 25 MM) INSYTE AUTOGUARD HAS BEEN FOUND WITH A HOLE IN THE CATHETER DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT DURING IV PLACEMENT, BLOOD BEGAN TO LEAK FROM A HOLE IN THE CATHETER NEAR THE HUB. 2ND OCCURRENCE ((B)(6) 2019): LOT# 9163647: RN WAS PLACING IV, ONCE THE IV WAS IN THE VEIN BLOOD WAS LEAKING FROM THE CATHETER NEAR THE HUB. IT WAS NOTICED THAT A HOLE WAS FOUND IN THE CATHETER. NO ONE WAS EXPOSED TO BLOOD (PPE WAS BEING WORN BY RN). CONTAMINATED SAMPLE IS AVAILABLE FOR INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 889917 | 22G X 1.00IN (0.9 X 25 MM) INSYTE AUTOGUARD | INTERVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 9163647 | 30382903814238 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |