inforMED
MalfunctionFOS

ARGYLE

Received Nov 9, 2023 · Event occurred Jul 1, 2023

Report 18101472 · MDR key 18101472

Device

Generic name

Catheter, Umbilical Artery

Manufacturer

Cardinal Health

Model number

8888160333

Catalog number

8888160333

Patient

Unknown

  • Device Embedded In Tissue or Plaque
  • Device Embedded In Tissue or Plaque

Narrative

Description of Event or Problem

UVC WAS SEEN TO BE MALPOSITIONED ON KUB (KIDNEY, URETER, AND BLADDER X-RAY). THE UMBILICAL AREA WAS CLEANED AND PREPPED WITH BETADINE. A TIME OUT WAS PERFORMED AT 6PM. THE LINE WAS REMOVED 2CM TO 6CM. ON REPEAT KUB THE CATHETER STILL APPEARED MALPOSITIONED. UPON A SECOND ATTEMPT TO FURTHER ADJUST THE LINE SEPARATED FROM ITSELF. IT SEPARATED AT APPROX. 4.5CM MARK. THE RETAINED PIECE WAS UNABLE TO BE VISUALIZED AT THE STUMP. A KUB WAS OBTAINED, REVEALING A PIECE OF CATHETER. DR. [REDACTED NAME], AND THE NICU FELLOW WERE NOTIFIED. DR. [REDACTED NAME] CALLED THE INTERVENTIONAL CARDIOLOGY ATTENDING, THE PEDIATRIC SURGICAL ATTENDING AND THE CARDIAC ANESTHESIA ATTENDING. DR. [REDACTED NAME] ALSO SPOKE IN PERSON TO THE PARENTS. MANUFACTURER RESPONSE FOR UVC, UVC (PER SITE REPORTER). [REDACTED DATE] INITIAL CONTACT SENT, INQUIRED ABOUT HARM AND ANY ADDITIONAL PROCEDURES REQUIRED FOR CARE. [REDACTED DATE] - CONNECTED WITH REP TO REPORT THE DETAILS OF THIS EVENT AND REQUEST AN RMA AND MAILER LABEL. [REDACTED DATE]- SAMPLE SHIPPED FEDEX.