MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC; COVIDIEN ARGYLE PERIPHERAL INSERTED CENTRAL CATHETER

Lot Number 1928200149

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2022

Event Type  malfunction  

Event Description

The picc line separated from the purple hub of the catheter and then pulled out of patient's arm.

• Brand Name: MEDTRONIC
• Type of Device: COVIDIEN ARGYLE PERIPHERAL INSERTED CENTRAL CATHETER
• Manufacturer (Section D): MEDTRONIC; 14643 dallas pkwy; dallas TX 75254
• MDR Report Key: 14086581
• MDR Text Key: 290057253
• Report Number: 14086581
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 1928200149
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/31/2022
• Distributor Facility Aware Date: 03/31/2022
• Date Report to Manufacturer: 03/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 27 DA
• Patient Sex: Female
• Patient Weight: 1 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White