MAUDE Adverse Event Report: UTAH MEDICAL PRODUCTS INC. PICC NATE 1.9 FRENCH; INTROAVASCULAR CATHETER

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation of Vessels (2135)

Event Date 02/16/2022

Event Type  malfunction  

Event Description

The perpherally inserted central catheter (picc) infiltrated.Upon further investigation it has been determined that there have been a total of three patient care events related to this brand of picc line that resulted in infiltration ot the neonate.The devices were found to be from the same lot.This was discovered from a common cause analysis.

Manufacturer Narrative

Utmd is reporting this event because the medical staff reported that the picc infiltrated into the patient outside of the vein during use.The hospital staff did not identify a fault with the picc, and did not determine what caused the infiltration.No permanent injury was reported in all three cases.No similar complaints for any lot have been reported.During the last three years (look-back period).

• Brand Name: PICC NATE 1.9 FRENCH
• Type of Device: INTROAVASCULAR 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: 14148006
• MDR Text Key: 298897116
• Report Number: 1718872-2022-00002
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: PC-2PS
• Device Lot Number: 1202164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2022
• Initial Date FDA Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 8 DA
• Patient Sex: Female
• Patient Weight: 1 KG