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

Catalog Number 4173505

Device Problems Fracture (1260); Use of Device Problem (1670)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Manufacturer Narrative

Utmd is reporting this event because the hospital staff stated that a segment of the tubing broke off the catheter.The patient was transferred to another facility for the removal of the tubing segment.

Event Description

Catheter tube broke while the tube was being repositioned.Infant transferred to another facility for the removal of the catheter.

• Brand Name: UMBILI-CATH
• Type of Device: UMBILICAL CATHETER
• Manufacturer (Section D): UTAH MEDICAL PRODUCTS, INC.; 7043 south 300 west; midvale UT 84047
• Manufacturer (Section G): UTAH MEDICAL PRODUCTS; 7043 south 300 west; midvale UT 84047
• Manufacturer Contact: ben shirley ; 7043 south 300 west; midvale, UT ; 8015661200
• MDR Report Key: 8874193
• MDR Text Key: 163806617
• Report Number: 1718873-2019-00002
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K940952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2023
• Device Catalogue Number: 4173505
• Device Lot Number: 1182060
• Was Device Available for Evaluation?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2019
• Date Manufacturer Received: 07/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 DA
• Patient Weight: 1