MAUDE Adverse Event Report: FENWAL, INC. PHLEBOTOMY KIT NEEDLE; CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS

Device Problem Particulates (1451)

Patient Problem No Information (3190)

Event Date 04/18/2016

Event Type  malfunction  

Event Description

A therapeutic phlebotomy kit needle was found with solid particles on the bevel.

• Brand Name: PHLEBOTOMY KIT NEEDLE
• Type of Device: CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS
• Manufacturer (Section D): FENWAL, INC.; 3 corporate dr. ste. 300; lake zurich IL 60047
• MDR Report Key: 5624468
• MDR Text Key: 44208422
• Report Number: 5624468
• Device Sequence Number: 1
• Product Code: KSR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Other Device ID Number: 1FE04R3611 / FM15C24056
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/25/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 04/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO