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

Catalog Number 14230

Device Problem Particulates (1451)

Patient Problem No Patient Involvement (2645)

Event Date 01/01/2014

Event Type  malfunction  

Event Description

The customer contact reported particulate.The customer contact reported that prior to patient use; brown flecks were noted in the drip chamber.The tubing set was replaced and the therapy was initiated.There were no reported adverse patient effects.No additional information was provided.

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.This report represents all the information known by the reporter upon query by hospira personnel.

• Brand Name: SECNDRY 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: 4353216
• MDR Text Key: 19354760
• Report Number: 9613251-2014-00173
• 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: 12/04/2014

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: 410824W
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2014
• Initial Date FDA Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2014
• 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