UMBILICAL CATHETER 3.5FR DL
Received Apr 29, 2022 · Event occurred Apr 20, 2022
Report MW5109453 · MDR key 14257490
Device
Product problems
- Device Markings/Labelling Problem
- Material Deformation
Patient
5 YR · Female
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
THIS IS A PREMATURE INFANT IN NICU WHO HAD AN UMBILICAL CATHETER. THIS CATHETER WAS PULLED FROM THE PATIENT ON (B)(6) 2022 AFTER PICC LINE PLACEMENT. THE UMBILICAL CATHETER WAS STRETCHED AND CURVED. WHEN IT WAS OUTSIDE THE PATIENT, THE CATHETER WAS NOTED TO HAVE JAGGED EDGES. THE NEONATAL NURSE PRACTITIONER STATED THAT SHE SAW NO ABNORMALITY WITH THE UMBILICAL CATHETER PRIOR TO PLACEMENT. THE NNP'S DO CHECK LINES FOR INTEGRITY PRIOR TO PLACEMENT. UPON REMOVAL, THIS LINE WAS COMPARED WITH A PACKAGED CATHETER. THE REMOVED CATHETER WAS STRETCHED AND THE MARKINGS DID NOT MATCH THE PACKAGED LINE CM MARKINGS. FDA SAFETY REPORT ID #:(B)(4)