MAUDE Adverse Event Report: COOK MEDICAL FNA NEEDLE; FINEE NEEDLE ASPIRATION

Lot Number C1162381

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/16/2016

Event Type  malfunction  

Event Description

Cook pro core 20 needle did not work and needle bent.No harm to pt.

• Brand Name: FNA NEEDLE
• Type of Device: FINEE NEEDLE ASPIRATION
• Manufacturer (Section D): COOK MEDICAL; bloomington IN 47402
• MDR Report Key: 5910160
• MDR Text Key: 53460318
• Report Number: MW5064390
• Device Sequence Number: 1
• Product Code: KNW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2018
• Device Lot Number: C1162381
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 95