MAUDE Adverse Event Report: HOSPIRA COSTA RICA LTD.

Lot Number UNK5H

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 01/01/2014

Event Type  malfunction  

Event Description

The customer contact reported a crack; subsequently a leak was noted.It was reported that an unspecified volume of solution leaked from a crack at an unspecified location of the tubing set.No specific details were provided.No info was provided if the event occurred during or prior to pt use; however, there were no reported adverse pt effects and no reported delay of therapy to any pt.No medical intervention were reported.Multiple unsuccessful attempts have been made to obtain add'l info.

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.The list number of the device that was in use is unk.The customer contact identified the device as a plumset; however, the customer contact was unable to provide the list of the device.This report represents all the info known by the reporter upon query by hospira personnel.

• Brand Name: UNK
• Type of Device: UNK
• Manufacturer (Section D): HOSPIRA COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer (Section G): HOSPIRA COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: juergen schmider, md, vp, gps ; 275 n. field dr.; bldg no. h2-1east, dept no. 097u; lake forest, IL 60045 ; 2242125740
• MDR Report Key: 3905817
• MDR Text Key: 4654197
• Report Number: 9615050-2014-03702
• Device Sequence Number: 1
• Product Code: FPK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: UNK5H
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1