MAUDE Adverse Event Report: HOSPIRA LTD. SECONDARY SET 34IN NDEHP W/EXT HOOK; 80FPA

Catalog Number 14230

Device Problem Particulates (1451)

Patient Problem No Patient Involvement (2645)

Event Date 02/11/2014

Event Type  malfunction  

Event Description

The customer contact reported particulate.The customer contact reported that after the protective cap was removed from the piercing pin of the tubing set, black particulate was noted on the tip of the piercing pin.The customer contact reported the black particulate looked like either black ink or dirt.The tubing set was replaced and the therapy was initiated.No additional info 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: SECONDARY SET 34IN NDEHP W/EXT HOOK
• Type of Device: 80FPA
• Manufacturer (Section D): HOSPIRA LTD.; carretera sanchez, km 18; 1/2 parque industrial; haina, san cristobal ; DR
• Manufacturer (Section G): HOSPIRA LTD.; carretera sanchez, km 18; 1/2 parque industrial; haina, san cristobal ; DR
• 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: 3832179
• MDR Text Key: 20787409
• Report Number: 9613251-2014-00050
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/11/2014

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: 14230
• Device Lot Number: 340564W
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/18/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2014
• Initial Date FDA Received: 03/07/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2013
• 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