MAUDE Adverse Event Report: HOSPIRA, INC. PLUM; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 1233605

Device Problems Backflow (1064); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 05/04/2020

Event Type  malfunction  

Event Description

Rn found small tear in tubing line, which caused some blood to backflow into the tubing.Total parenteral nutrition (tpn) was running at the time.Unable to identify why or how tubing teared.Tubing not send to supply chain.

• Brand Name: PLUM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): HOSPIRA, INC.; 375 n. field dr; lake forest IL 60045
• MDR Report Key: 11321044
• MDR Text Key: 231589161
• Report Number: 11321044
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1233605
• Device Catalogue Number: 1233605
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/03/2021
• Date Report to Manufacturer: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22315 DA