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

Model Number 1194802

Device Problems Device Slipped (1584); Chemical Spillage (2894)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2018

Event Type  malfunction  

Event Description

The clear flexible tubing that goes into the spike slid out of the spike causing tpn to spill.When i place the flexible tubing back into the bottom of the spike, it pulls out very easily.The device was retained however packing as disposed of.This did not negatively impact the patient.

• Brand Name: PLUM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): HOSPIRA, INC.; highway 301 north; rocky mount NC 27801
• MDR Report Key: 7442745
• MDR Text Key: 105908379
• Report Number: 7442745
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787005179
• UDI-Public: (01)10887787005179
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1194802
• Device Catalogue Number: 1194802
• 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: 04/10/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1