inforMED
MalfunctionPEZ

CENTRAL LINE CATHETER KIT

Received Jan 6, 2026 · Event occurred Dec 26, 2025

Report MW5181818 · MDR key 23975733

Device

Generic name

Central Venous Catheter Dressing Change Kit

Manufacturer

Unk

Model number

ECVC6975A

Lot number

2055102890

Product problems

  • Component Missing
  • Failure to Advance

Patient

80 YR · Male

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

APRN WAS PLACING A CENTRAL LINE ON THE PATIENT AND FOUND THERE WAS NO DILATOR IN THE KIT. AN ADDITIONAL KIT--ONE OF THE SAME REORDER NUMBER, EXPIRATION DATE, AND LOT NUMBER--WAS OPENED TO OBTAIN A DILATOR, BUT IT WAS MISSING FROM THAT KIT AS WELL. APRN, THIS RN, AND AN ADDITIONAL RN SEARCHED BOTH KITS AND CONFIRMED NO DILATOR WAS PRESENT. IT WAS ALSO NOTED THAT BOTH KITS WERE MISSING 1 OF THE 3 SODIUM CHLORIDE FLUSHES. AN ADDITIONAL KIT--WITH A DIFFERENT REORDER NUMBER, EXPIRATION DATE, AND LOT NUMBER--WAS OPENED AND A DILATOR WAS PRESENT ALLOWING THE PROVIDER TO PROCEED WITH CENTRAL LINE PLACEMENT. DILATOR WAS SUCCESSFULLY UTILIZED AND PROVIDER PROCEEDED WITH LINE PLACEMENT BUT WAS THEN UNABLE TO THREAD THE GUIDE WIRE THROUGH THE CVC FROM THE FAULTY KIT. THE CVC FROM THE ADDITIONAL KIT (DIFFERENT REORDER NUMBER, EXPIRATION DATE, AND LOT NUMBER) WAS THEN ATTEMPTED AND THE GUIDE WIRE WAS SUCCESSFULLY THREADED THROUGH THIS CVC. AFTERWARDS, THE PROVIDED COMPARED THE CVC SHE WAS UNABLE TO THREAD WITH THE GUIDE WIRE TO THE OTHER CVC FROM THE KIT OF THE SAME LOT NUMBER AND IT WAS NOTED THAT THE LUMEN OPENING WAS SMALLER IN SIZE AND WOULD NOT ALLOW THE GUIDE WIRE TO PASS THROUGH. PT CODE: 4582. DEVICE CODES: 2306, 2524. REF REPORT: MW5181819.