MAUDE Adverse Event Report: COVIDIEN MANUFACTURING SOLUTIONS, SA COVIDIEN; UMBILICAL VENOUS CATHETER

Lot Number 1730500084/173470

Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/13/2018

Event Type  Injury  

Event Description

Attempt to remove picc line.Physician worked on removal for 1 hr.When the catheter broke off leaving a portion inside the baby.Had to be surgically removed in the operating room.

• Brand Name: COVIDIEN
• Type of Device: UMBILICAL VENOUS CATHETER
• Manufacturer (Section D): COVIDIEN MANUFACTURING SOLUTIONS, SA
• MDR Report Key: 7938554
• MDR Text Key: 123189128
• Report Number: MW5080374
• 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: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 1730500084/173470
• Was Device Available for Evaluation?: No
• 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): Other
• Patient Age: 14 DA
• Patient Weight: 4