MAUDE Adverse Event Report: HOSPIRA INC. PRIMAY PLUMSET 2 CLAVE Y SITES; TUBING, IV ADMINISTRATION SET

Catalog Number 14243-28

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Information (3190)

Event Date 04/12/2016

Event Type  malfunction  

Event Description

The device has an access port on the cassette that comes with a cap.The cap must be removed and a clave must be added or the system draws in air causing a risk for air embolism.This must be done with each tubing that is used.The staff must retrieve a microclave device to add to each tubing that is used to avoid the concern for air embolism.

• Brand Name: PRIMAY PLUMSET 2 CLAVE Y SITES
• Type of Device: TUBING, IV ADMINISTRATION SET
• Manufacturer (Section D): HOSPIRA INC.; 275 north field drive; bldg h2; lake forest IL 60045
• MDR Report Key: 5619176
• MDR Text Key: 44009936
• Report Number: 5619176
• Device Sequence Number: 1
• Product Code: FPA
• 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: 04/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 14243-28
• Device Lot Number: 58178
• 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: 04/26/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2016
• 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