MAUDE Adverse Event Report: MEDLINE; CATHETER, UMBILICAL

Lot Number 1804500080

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/25/2018

Event Type  malfunction  

Event Description

After placement, but before fluids infused, the umbilical catheter cracked.The catheter was removed and replaced in infant.

• Type of Device: CATHETER, UMBILICAL
• Manufacturer (Section D): MEDLINE; three lakes drive; northfield IL 60093
• MDR Report Key: 8324893
• MDR Text Key: 135708720
• Report Number: 8324893
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/05/2019,01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 1804500080
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/05/2019
• Date Report to Manufacturer: 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1