MAUDE Adverse Event Report: HOSPIRA HOLDINGS DE COSTA RICA LTD. PLUMSET CLAVE YSITE 104IN NDEHP; 80FPA

Catalog Number 14242

Device Problem Particulates (1451)

Patient Problem No Patient Involvement (2645)

Event Date 02/17/2015

Event Type  malfunction  

Event Description

The customer contact reported particulate.The tubing set was to be used to deliver an unspecified concentration of ganciclovir.The customer contact reported that prior to patient use; an opaque and gelatinous particulate was noted through out the tubing set.The tubing set was replaced and therapy was initiated.It was reported that there was two hour delay in therapy.The customer contact reported that the device was tested by microbiology and no fungi or bacteria were found.There were no reported adverse patient effects and no medical interventions were required.No additional information was provided.

Manufacturer Narrative

The device was received.Investigation is not complete.This report represents all the information known by the reporter upon query by hospira personnel.

• Brand Name: PLUMSET CLAVE YSITE 104IN NDEHP
• Type of Device: 80FPA
• Manufacturer (Section D): HOSPIRA HOLDINGS DE COSTA RICA LTD.; zona franca global; la aurora de heredia ; CS
• Manufacturer (Section G): HOSPIRA COSTA RICA LTD.; zona franca global; la aurora de heredia ; CS
• Manufacturer Contact: juergen schmider, md, vp. ; 275 n. field dr.; bldg. no. h2-1east, dept no. 097u; lake forest, IL 60045 ; 2242125740
• MDR Report Key: 4602556
• MDR Text Key: 5468910
• Report Number: 9615050-2015-00578
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14242
• Device Lot Number: 461715H
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/27/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2015
• Initial Date FDA Received: 03/06/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GANCICLOVIR; UNK MANUFACTURER