inforMED
MalfunctionOFD

CVC BUNDLE

Received Sep 18, 2020 · Event occurred Aug 21, 2020

Report 10553074 · MDR key 10553074

Device

Generic name

Catheter Introducer Kit

Lot number

2020060950

Product problems

  • Filling Problem

Patient

18615 DA

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

MULTIPLE ATTEMPTS WERE MADE TO ACCESS THE RIGHT SUBCLAVIAN VEIN FOR LINE INSERTION WITH SYRINGE AND "PINK" COLORED NEEDLE (UNK GAUGE) THAT IS IN THE TRIPLE LUMEN 16CM, 7 FRENCH CVC KIT ( 0.035" GUIDEWIRE). THE SYRINGE WOULD FILL AIR WITHOUT BLOOD RETURN. SEVERAL ATTEMPTS TO ACCESS SUBCLAVIAN VEIN WERE UNSUCCESSFUL. THE LINE PLACEMENT WAS ATTEMPTED AGAIN WITH A NEW 16CM, 7 FRENCH 3-LUMEN CVC KIT ON THE RIGHT SIDE AND AGAIN NOTED AIR IN SYRINGE. AFTER CHANGING SYRINGES WITH SAME RESULT, A 2-LUMEN KIT WAS OPENED TO ATTEMPT A NEW SYRINGE/ NEEDLE. THE VEIN WAS ABLE TO BE ACCESSED ON THE FIRST ATTEMPT WITH NEW NEEDLE FROM DIFFERENT CVC KIT AND ACCESS WAS OBTAINED & SECURED WITHOUT DIFFICULTY, USING THE 3-LUMEN CATHETER--NO FURTHER ISSUES NOTED. ONCE LINE WAS SECURED, FLUSHED THE NEEDLE FROM THE FAULTY 3-LUMEN KIT AND NOTED LEAKING AT THE HUB/ FINGER GRIP PORTION OF THE NEEDLE. THE NEEDLE WAS FLUSHED AND PLACED IN A SHARPS HOLDER AND SAVED FOR DEFECTIVE PRODUCT REVIEW.