MAUDE Adverse Event Report: HOSPIRA, INC. LIFESHIELD 60" SMALLBORE EXT SET W/CLAMP, ROTATING LEUR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 1440228

Device Problem Flushing Problem (1252)

Patient Problem Insufficient Information (4580)

Event Date 07/06/2021

Event Type  malfunction  

Event Description

Was attempting to use a smallbore extension set but the tubing would not flush.Was unable to give any medications through the tubing.

• Brand Name: LIFESHIELD 60" SMALLBORE EXT SET W/CLAMP, ROTATING LEUR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): HOSPIRA, INC.; highway 301 north; rocky mount NC 27801
• MDR Report Key: 12149080
• MDR Text Key: 260956930
• Report Number: 12149080
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1440228
• Device Catalogue Number: 14402-28
• Device Lot Number: 5271769
• 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: 07/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1