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U.S. Department of Health and Human Services

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

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UTAH MEDICAL PRODUCTS, INC. UMBILI-CATH CATHETER, UMBILICAL ARTERY Back to Search Results
Model Number 4183505
Device Problems Leak/Splash (1354); Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/31/2017
Event Type  malfunction  
Manufacturer Narrative
The following elements have blank data.
 
Event Description
Male infant (twin) delivered via spontaneous vaginal delivery (svd) at (b)(6). Intubated at 2 min of life. Admitted to nicu, started on high-frequency oscillatory ventilation (hfov). Uvc & uac placed on admission to nicu. Uac removed & replaced w/ uac single lumen 3. 5 fr in late october. Skin surrounding umbilicus & umbilicus cleaned with povidone-iodine. Uac was secured w/ suture at 10cm. No complications reported w/ insertion procedure. Six days later, the rn noted that the uac was leaking. It was clamped in order to change out lines, blood was noted to back up into the uac. The rn noted a small hole/leak in the catheter. The nnp was called to the bedside to assess. The uac was discontinued without problem. Specific site (cm mark) of leaking was not provided. A uvc also placed initially (four days pre-uac) for nutritional support, removed & replaced the next day due to "low lying" position, d/c'd six days after initial placement.
 
Event Description
Male infant (twin) delivered via spontaneous vaginal delivery (svd) at 23wk/3d, wt: 1 lb/7. 3 oz. Intubated at 2 min of life. Admitted to nicu, started on high-frequency oscillatory ventilation (hfov). Uvc & uac placed on admission to nicu. Uac removed & replaced w/ uac single lumen 3. 5 fr in late october. Skin surrounding umbilicus & umbilicus cleaned with povidone-iodine. Uac was secured w/ suture at 10cm. No complications reported w/ insertion procedure. Six days later, the rn noted that the uac was leaking. It was clamped in order to change out lines, blood was noted to back up into the uac. The rn noted a small hole/leak in the catheter. The nnp was called to the bedside to assess. The uac was discontinued without problem. Specific site (cm mark) of leaking was not provided. A uvc also placed initially (four days pre-uac) for nutritional support, removed & replaced the next day due to "low lying" position, d/c'd six days after initial placement.
 
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Brand NameUMBILI-CATH
Type of DeviceCATHETER, UMBILICAL ARTERY
Manufacturer (Section D)
UTAH MEDICAL PRODUCTS, INC.
7043 south 300 west
midvale UT 84047 1048
MDR Report Key7181788
MDR Text Key275049512
Report Number7181788
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4183505
Other Device ID NumberVASCULAR - SINGLE LUMEN UAC 3
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/28/2017
Event Location Hospital
Date Report to Manufacturer12/28/2017
Was Device Evaluated by Manufacturer? No Answer Provided
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: 01/11/2018 Patient Sequence Number: 1
Treatment
THIS INFANT WAS ON VENTILATOR SUPPORT WITH A PICC; THIS INFANT WAS ON VENTILATOR SUPPORT WITH A PICC
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