MAUDE Adverse Event Report: HOSPIRA COSTA RICA LTD. PLUMSET W/CLAVE SEC PORT CLAVE Y-SITE; 80FRN

Catalog Number 12030

Device Problem Particulates (1451)

Patient Problem No Patient Involvement (2645)

Event Date 10/06/2014

Event Type  malfunction  

Event Description

The customer contact reported particulate.The tubing set was to be used to deliver an unspecified medication at an unspecified rate.It was reported that during product handling, prior to patient use, particulate was noted inside the cassette of the tubing set.The customer contact described the particulate as dirty, dark particles adhered to the inside of the cassette of the tubing set.There was no reported delay of therapy critical to any patient.No additional details were provided.

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.The reporter was contacted and info on reprocessing of the device was requested; however, the info was not obtained.This report represents all the info known by the reporter upon query by hospira personnel.

• Brand Name: PLUMSET W/CLAVE SEC PORT CLAVE Y-SITE
• Type of Device: 80FRN
• 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 ; 275 n. field dr; bldg.no. h2-1e, dept no.097u; lake forest, IL 60045 ; 2242125740
• MDR Report Key: 4293311
• MDR Text Key: 5054199
• Report Number: 9615050-2014-06161
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K982159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 12030
• Device Lot Number: 110885H
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1