HAWKINS III FLEXSTRAND BLN 20GA X 5CM
Received Jan 10, 2023 · Event occurred Dec 29, 2022
Report 0001625425-2023-00930 · MDR key 16134004
Device
Generic name
Bln
Manufacturer
Argon Medical DevicesModel number
253050Catalog number
253050
Lot number
11438372
Product problems
- Inadequacy of Device Shape and/or Size
- Inadequacy of Device Shape and/or Size
- Activation Problem
Patient
Unknown
- Needle Stick/Puncture
- Insufficient Information
- Needle Stick/Puncture
- Insufficient Information
Narrative
Additional Manufacturer Narrative
A REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS FOR THIS LOT WAS CONDUCTED, AND NO DEVIATIONS AND NON-CONFORMANCES WERE RECORDED. A REVIEW OF RETURNED PRODUCT FROM THE CUSTOMER WAS PERFORMED BY VISUALLY INSPECTING THE FOUR UNOPENED SAMPLES RETURNED FROM THE CUSTOMER AND NO DAMAGE WAS FOUND ON THE PRODUCT. CUSTOMER DID NOT RETURN FAULTY DEVICE TO ARGON FOR INVESTIGATION. RETURNED SAMPLES WERE MEASURED DIMENSIONALLY AND THEY WERE ALL PER DRAWINGS AND SPECIFICATIONS. SAMPLE PASSED SMOOTHLY WITH FEEL MINOR INTERFERENCE AND ALL TOLERANCE WERE IN THE SPECIFICATION. SAMPLE WAS TESTED FUNCTIONALLY BY PASSING CANNULA THROUGH NEEDLE WITHOUT INTERFERENCE AND HENCE COMPLAINT WAS NOT CONFIRMED. NO FURTHER EVALUATION OR CORRECTIVE ACTIONS ARE NEEDED AT THIS TIME.
Description of Event or Problem
THE WIRE IS MOVING BACK AFTER BEING PLACED FOR BREAST NEEDLE LOC, THE WIRE DOESN'T APPEAR TO BE OPENING UP AT THE END GIVING IT THAT "V" WHICH HOLDS IT IN PLACE.
Description of Event or Problem
THE WIRE IS MOVING BACK AFTER BEING PLACED FOR BREAST NEEDLE LOC, THE WIRE DOESN'T APPEAR TO BE OPENING UP AT THE END GIVING IT THAT "V" WHICH HOLDS IT IN PLACE.
Additional Manufacturer Narrative
SAMPLE IS UNAVAILABLE FOR EVALUATION. WITHOUT SUCH EVIDENT TO REVIEW, THE COMPLAINT CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION IS PROVIDED IN THE FUTURE, A FOLLOW-UP REPORT WILL BE SUBMITTED.