UMBILI-CATH
Received Jan 26, 2022 · Event occurred Dec 21, 2021
Report 1718873-2022-00001 · MDR key 13362322
Device
Generic name
Umbilical Catheter
Manufacturer
Utah Medical Products, IncCatalog number
4273505
Lot number
1212617
Product problems
- Material Split, Cut or Torn
- Material Split, Cut or Torn
Patient
28 WK · 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 SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE SEVERED SEGMENT OF CATHETER TUBE FROM THE PATIENT. THE HOSPITAL STAFF CONFIRMED THAT THE CATHETER WAS SUTURED IN PLACE AND THEN SECUREPORTIV ADHESIVE WAS APPLIED TO THE CATHETER AND SUTURES. THE HOSPITAL STAFF ALSO CONFIRMED THAT NEITHER THE ADHESIVE NOR SUTURES WERE LOOSENED OR REMOVED PRIOR TO THE CATHETER REMOVAL ATTEMPT. THE INSTRUCTIONS FOR USE PROVIDED WITH UTMD'S CATHETER STATE TO LOOSEN SECUREMENTS BEFORE ADJUSTING THE POSITION OF THE CATHETER.
Description of Event or Problem
ON (B)(6) 2021, THE PATIENT REQUIRED A UVC PLACEMENT. ON (B)(6) 2021, AN ORDER WAS PLACED TO DISCONTINUE THE USE OF THE UVC. DURING REMOVAL, THE CATHETER WAS SEVERED AND A SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE REMAINING INDWELLING CATHETER SEGMENT. THE PATIENT TOLERATED THE PROCEDURE WELL AND THE UVC WAS COMPLETELY REMOVED. THE USER CONFIRMED THAT THE SECUREMENTS, SUTURES AND SECUREPORTIV ADHESIVE, WERE NOT REMOVED PRIOR TO THE REMOVAL ATTEMPT.
Description of Event or Problem
ON (B)(6) 2021, THE PATIENT REQUIRED A UVC PLACEMENT. ON 12-21-2021, AN ORDER WAS PLACED TO DISCONTINUE THE USE OF THE UVC. DURING REMOVAL, THE CATHETER WAS SEVERED AND A SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE REMAINING INDWELLING CATHETER SEGMENT. THE PATIENT TOLERATED THE PROCEDURE WELL AND THE UVC WAS COMPLETELY REMOVED. THE USER CONFIRMED THAT THE SECUREMENTS, SUTURES AND SECUREPORTIV ADHESIVE, WERE NOT REMOVED PRIOR TO THE REMOVAL ATTEMPT.
Additional Manufacturer Narrative
UTMD IS REPORTING THIS EVENT BECAUSE THE HOSPITAL STAFF STATED THAT A SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE SEVERED SEGMENT OF CATHETER TUBE FROM THE PATIENT. THE HOSPITAL STAFF CONFIRMED THAT THE CATHETER WAS SUTURED IN PLACE AND THEN SECUREPORTIV ADHESIVE WAS APPLIED TO THE CATHETER AND SUTURES. THE HOSPITAL STAFF ALSO CONFIRMED THAT NEITHER THE ADHESIVE NOR SUTURES WERE LOOSENED OR REMOVED PRIOR TO THE CATHETER REMOVAL ATTEMPT. THE INSTRUCTIONS FOR USE PROVIDED WITH UTMD'S CATHETER STATE TO LOOSEN SECUREMENTS BEFORE ADJUSTING THE POSITION OF THE CATHETER.