UMBILI-CATH
Received May 23, 2023 · Event occurred May 6, 2023
Report 1718873-2023-00001 · MDR key 16987272
Device
Generic name
Umbilical Catheter
Manufacturer
Utah Medical Products, IncModel number
Dual-Lumen SiliconeCatalog number
4273505
Lot number
1223017
Product problems
- Material Split, Cut or Torn
- Material Split, Cut or Torn
Patient
7 DA · Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
UTMD IS REPORTING THIS EVENT BECAUSE THE HOSPITAL STAFF STATED THAT A INTERVENTIONAL RADIOLOGY WAS PERFORMED TO REMOVE THE REMAINING CATHETER FROM THE PATIENT. THE MGR NICU PEDS AT USER FACILITY STATED THAT THE PATIENT WAS STABLE AND THERE WAS NO KNOWN LONG TERM EFFECTS TO THE PATIENT. AFTER INVESTIGATION AT UTMD, THE RETURNED CATHETER HAD BEEN DAMAGED WITH SHARP INSTRUMENT AND THEN TORN. THE RETURNED CATHETER WAS PULL TESTED AT UTMD AND MET SPECIFICATIONS. THE IFU HAS CAUTIONS INDICATING TO TAKE CARE NOT TO DAMAGE THE SOFT SILICONE CATHETER TUBING DURING USE. (SEE IFU 58078 REV 022322).
Description of Event or Problem
ON (B)(6) 2023. THE CATHETER BROKE DURING REMOVAL. THE REMAINING PIECE REMAINED INTERNAL AND THE INFANT SUBSEQUENTLY HAD TO BE SHIPPED TO THE HIGHER LEVEL OF CARE FOR REMOVAL. THE REMAINING CATHETER WAS REMOVED AT ANOTHER FACILITY WITH INTERVENTIONAL RADIOLOGY.