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

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  

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.

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.

• Brand Name: UMBILI-CATH
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): UTAH MEDICAL PRODUCTS, INC.; 7043 south 300 west; midvale UT 84047 1048
• MDR Report Key: 7181788
• MDR Text Key: 96976473
• Report Number: 7181788
• 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: Nurse
• 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 Received: 01/11/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 4183505
• Other Device ID Number: VASCULAR - SINGLE LUMEN UAC 3
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/28/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/28/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: THIS INFANT WAS ON VENTILATOR SUPPORT WITH A PICC; THIS INFANT WAS ON VENTILATOR SUPPORT WITH A PICC