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

Lot Number 1163201

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 05/04/2017

Event Type  Injury  

Event Description

The umbilical vein catheter snapped when it was being gently retracted by the physician.The physician was able to remove the remainder of the catheter without difficulty.

• Brand Name: UMBILI - CATH
• Type of Device: DUAL LUMEN SILICONE UMBILICAL CATHETER
• Manufacturer (Section D): UTAH MEDICAL PRODUCTS, INC.; 7043 south 30 ; west midvale UT 84047
• MDR Report Key: 6600805
• MDR Text Key: 76395703
• Report Number: MW5070071
• Device Sequence Number: 1
• Product Code: FOS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2022
• Device Lot Number: 1163201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 3