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

Catalog Number UNKNOWN

Device Problem Fracture (1260)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 08/21/2018

Event Type  malfunction  

Manufacturer Narrative

Utmd is reporting this event because the hospital staff reported that a dual lumen umbili-cath broke during removal from a 24 week gestation triplet, and a surgical procedure was required to remove a segment of the tubing from the patient.The hospital staff reported that the baby later died directly related to incidences of extreme prematurity, not from the uvc incident.

Event Description

While removing a dual lumen umbili-cath from the patient the tubing broke.A surgical procedure was performed to remove a segment of the tubing from the patient.

• Brand Name: UMBILI-CATH
• Type of Device: UMBILICAL CATHETER
• Manufacturer (Section D): UTAH MEDICAL PRODUCTS, INC.; 7043 south 300 west; midvale UT 84047
• Manufacturer Contact: ben shirley ; 7043 south 300 west; midvale, UT 84047 ; 8015661200
• MDR Report Key: 7928485
• MDR Text Key: 122484031
• Report Number: 1718873-2018-00002
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/21/2018
• Device Age: 1 WK
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2018
• Date Manufacturer Received: 09/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 WK
• Patient Weight: 1