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

Model Number DUAL-LUMEN SILICONE

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/26/2019

Event Type  malfunction  

Event Description

Infant delivered at 41wk/5d gestation, in nicu with 5fr.Double-lumen umbilical venous catheter (uvc) in place.The catheter was noted to have been sutured at 12 cm for securing purposes.Upon removal of the uvc, the catheter reportedly "snapped" at the 4cm mark during removal.The remainder of the catheter was removed with tweezers.

• Brand Name: UMBILI-CATH
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): UTAH MEDICAL PRODUCTS, INC.; 7043 south 300 west; midvale UT 84047
• MDR Report Key: 8678413
• MDR Text Key: 147339826
• Report Number: 8678413
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DUAL-LUMEN SILICONE
• Device Catalogue Number: 4275005
• Device Lot Number: 1181850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/03/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4 DA
• Patient Weight: 4