JELCO
Received Feb 1, 2021
Report 3012307300-2021-00539 · MDR key 11258401
Device
Generic name
Peripheral Intravenous Catheter
Manufacturer
Smiths Medical International, Ltd.Catalog number
4030-AI
Product problems
- Material Too Rigid or Stiff
- Material Too Rigid or Stiff
Patient
Not reported
- Vasculitis
- Vasculitis
Narrative
Additional Manufacturer Narrative
TWO PHOTOS WERE SENT IN-THE TWO FINISHED PRODUCTS NOTED TO BE IDENTICAL. IN PICTURE TWO THERE IS A 22G CATHETER ASSEMBLY AND A 20G CATHETER ASSEMBLY. WITHOUT THE DEFECTIVE UNIT, THE FAILURE INVESTIGATION WAS UNABLE TO BE CARRIED OUT. NO TESTING OR VISUAL INSPECTION COULD BE PERFORMED, AS NO PRODUCT WAS MADE AVAILABLE FOR EVALUATION.
Description of Event or Problem
INFORMATION WAS RECEIVED THAT DIFFICULTIES ARE BEING OBSERVED WITH INCREASED FREQUENCY WITH THE NEW JELCO. UPON PLACEMENT,DUE TO THE RIGIDITY OF THE MATERIAL, IT IS DISPLACED INTRAVENOUSLY AFTER THE PUNCTURE. IN MOST CASES THIS CAUSES THE RUPTURE OF THE VESSEL. ADDITIONALLY, SINCE USING THESE CATHETERS THE RATE OF PHLEBITIS HAS INCREASED.