UMBILI-CATH
Received Jul 8, 2025 · Event occurred May 22, 2025
Report 1718873-2025-00002 · MDR key 22443001
Device
Generic name
Umbilical Catheter
Manufacturer
Utah Medical Products, Inc.Catalog number
4173505
Lot number
UNKNOWN
Product problems
- Material Split, Cut or Torn
- Material Split, Cut or Torn
Patient
NA · 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 STERNAL REOPENING AT THE BEDSIDE WAS REQUIRED TO RETRIEVE THE REMAINING CATHETER SEGMENT FROM THE PATIENT. PRODUCT HAS NOT BEEN RETURNED TO UTMD FOR EVALUATION.
Description of Event or Problem
RIGHT ARTERIAL (RA) LINE REMOVAL WAS ORDERED. PATIENT PRE-SEDATED WITH KETAMINE AND HYDROMORPHONE BOLUS. CVS REMOVED THE LINE AND NOTED THAT PART OF THE RA LINE HAD SNAPPED AND BROKEN OFF INSIDE THE PATIENT. THE END LOOKED CLEAN, BUT IT WAS AT THE 5CM MARK. MINIMAL BLEEDING AT THE SITE WAS NOTED, AND CVS HELD PRESSURE UNTIL IT STOPPED. CVS HAD TO LEAVE AFTER, BUT WE NOTIFIED THAT NP, WHO NOTIFIED THE STAFF MD. TWO VIEW X-RAYS WERE TAKEN. CVS LATER HAD TO COME BACK AND DO A STERNAL REOPENING AT THE BEDSIDE TO RETRIEVE THE REMAINING SEGMENT OF RA LINE.
Description of Event or Problem
RIGHT ARTERIAL (RA) LINE REMOVAL WAS ORDERED. PATIENT PRE-SEDATED WITH KETAMINE AND HYDROMORPHONE BOLUS. CVS REMOVED THE LINE AND NOTED THAT PART OF THE RA LINE HAD SNAPPED AND BROKEN OFF INSIDE THE PATIENT. THE END LOOKED CLEAN, BUT IT WAS AT THE 5CM MARK. MINIMAL BLEEDING AT THE SITE WAS NOTED, AND CVS HELD PRESSURE UNTIL IT STOPPED. CVS HAD TO LEAVE AFTER, BUT WE NOTIFIED THAT NP, WHO NOTIFIED THE STAFF MD. TWO VIEW X-RAYS WERE TAKEN. CVS LATER HAD TO COME BACK AND DO A STERNAL REOPENING AT THE BEDSIDE TO RETRIEVE THE REMAINING SEGMENT OF RA LINE.
Additional Manufacturer Narrative
UTMD IS REPORTING THIS EVENT BECAUSE THE HOSPITAL STAFF STATED THAT A STERNAL REOPENING AT THE BEDSIDE WAS REQUIRED TO RETRIEVE THE REMAINING CATHETER SEGMENT FROM THE PATIENT. AFTER THE MEDWATCH REPORT NUMBER 1718873-2025-00002 WAS FILED ON 07/08/2025, UTMD RECEIVED THE RETURNED UNIT. DURING INVESTIGATION AT UTMD, IT WAS FOUND THAT THE RETURNED CATHETER HAD BEEN CUT DURING USE WITH SHARP INSTRUMENT AND THEN PULLED APART. A REMAINING PORTION OF 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 57080 REV. 022322).