MAUDE Adverse Event Report: UTAH MEDICAL PRODUCTS UMBILI-CATH CATHETER, UMBILICAL ARTERY

Device Problem Leak/Splash (1354)

Patient Problem Fluid Discharge (2686)

Event Date 01/11/2018

Event Type  malfunction  

Manufacturer Narrative

The following elements have blank data.

Event Description

Rn assessed patient 21:00. No leaking noted from uac when started assessment. Turned patient from left side to supine position. At 21:05, noted leaking of very small amount of blood from uac catheter where actual catheter meets the hub. Uac clamped and advanced practitioner immediately contacted and came to bedside. Uac line examined and leaking from actual uac confirmed. Uac removed and intra lipids-nutrition (il) infusion discontinued. Feeds advanced, and rn instructed to recheck blood sugar level at 23:00, to determine if patient needs peripheral intravenous (piv) placed for additional intravenous fluids (ivfs).

Event Description

Rn assessed patient 21:00. No leaking noted from (b)(6) when started assessment. Turned patient from left side to supine position. At 21:05, noted leaking of very small amount of blood from (b)(6) catheter where actual catheter meets the hub. (b)(6) clamped and advanced practitioner immediately contacted and came to bedside. (b)(6) line examined and leaking from actual (b)(6) confirmed. (b)(6) removed and il infusion discontinued. Feeds advanced, and rn instructed to recheck blood sugar level at 23:00, to determine if patient needs piv placed for additional ivfs.

• Brand Name: UMBILI-CATH
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): UTAH MEDICAL PRODUCTS; 7043 south 300 west; midvale UT 84047
• MDR Report Key: 7224259
• MDR Text Key: 273194451
• Report Number: 7224259
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Other Device ID Number: SINGLE-LUMEN POLYURETHANE UMB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/15/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 01/29/2018 Patient Sequence Number: 1

Treatment

NOT KNOWN.