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

Model Number 888160333

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 06/08/2018

Event Type  Injury  

Event Description

The uvc line was pulled back from 6.75 to 4 cm due to concern on x-ray that the line was in an unfavorable position.When pulling line back, there was backup of blood in the catheter that was leaking onto the baby's diaper.Upon examination, it was noted that the catheter had been severed in half due to an unknown cause.The remainder of the line was able to be retrieved.Lab work was ordered to rule out infection.A new line was placed to administer iv nutrition.Iv antibiotics were ordered prophylactically.

• Brand Name: UMBILICAL VESSEL CATHETER
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN MANUFACTURING SOLUTIONS SA; 15 hampshire st; mansfield, MA 02048
• MDR Report Key: 7734971
• MDR Text Key: 115556714
• Report Number: 7734971
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 888160333
• Device Lot Number: UNKNOWN
• 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: 07/03/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/31/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 2 DA
• Patient Weight: 2