UMBILI-CATH
Received Feb 9, 2024 · Event occurred Jan 18, 2024
Report 1718873-2024-00001 · MDR key 18677307
Device
Generic name
Umbilical Catheter
Manufacturer
Utah Medical Products, IncCatalog number
4273505
Lot number
1230384
Product problems
- Material Split, Cut or Torn
- Material Split, Cut or Torn
Patient
NA · Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
ON 1/18/2024, CATHETER BROKE DURING REMOVAL BY PHYSICIAN ASSISTANT. THE REMAINING CATHETER WAS REMOVED WITH SUB XYPHOID SURGICAL RE-ENTRY.
Additional Manufacturer Narrative
UTMD IS REPORTING THIS EVENT BECAUSE THE HOSPITAL STAFF STATED THAT A SUB XYPHOID SURGICAL RE-ENTRY WAS PERFORMED TO REMOVE THE REMAINING CATHETER FROM THE PATIENT. THE CT SURGERY ADVANCED LEAD AT THE USER FACILITY STATED THAT THE PATIENT IS DOING WELL. 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 DURING USE. (SEE IFU 57078 REV 022322).