MAUDE Adverse Event Report: UTAH MEDICAL PRODUCTS, INC PICC-NATE

Catalog Number PB-3PS

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

Utmd is reporting this event because the user facility reported that the catheter broke during removal.Severed segment was removed using a surgical procedure.

Event Description

When the hospital staffs were removing the catheter, the catheter broke, and a segment of the catheter remains in the patient.Another procedure was performed to remove the segment.

• Brand Name: PICC-NATE
• Type of Device: PICC
• Manufacturer (Section D): UTAH MEDICAL PRODUCTS, INC; 7043 south 300 west; midvale UT 84047
• Manufacturer (Section G): 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: 15448497
• MDR Text Key: 306076542
• Report Number: 1718873-2022-00004
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K001874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PB-3PS
• Device Lot Number: 1212157
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention