FDA Adverse Event Malfunction Summary report: N

JAMSHIDI

MDR report key: 2903491 · Received January 4, 2013

Report

Report Number
2903491
Event Type
Malfunction
Date Received
January 4, 2013
Date of Event
December 28, 2012
Report Date
January 4, 2013
Manufacturer
CAREFUSION
Product Code
KNW
Product Problem
Yes
Report Source
User Facility report
Reporter Location
FL, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

AFTER NEEDLE WAS REMOVED FROM PATIENT, PHYSICIAN NOTED TIP OF NEEDLE WAS BENT. THIS MADE IT VERY DIFFICULT TO REMOVE THE SPECIMEN FROM THE NEEDLE.======================MANUFACTURER RESPONSE FOR BONE MARROW ASPIRATION NEEDLE, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================1. CAN YOU PLEASE TELL ME IF THE NEEDLE WAS BENT PRIOR TO PATIENT USE? THE PHYSICIAN INSPECTED THE NEEDLE PRIOR TO USE- NO BENDING NOTED.2. AT WHAT STAGE IN THE PROCEDURE WAS THE BENT CONDITION IDENTIFIED? WHEN THE BONE/CORE SPECIMEN WAS OBTAINED AND PHYSICIAN ATTEMPTED TO USE STYLET TO PUSH SPECIMEN OUT OF NEEDLE. THE STYLET WOULD NOT FIT INTO NEEDLE DUE TO ONE OF THE "TIPS" ON THE NEEDLE BEING BENT INWARD.3. WHAT BONE STRUCTURE WAS THE NEEDLE BEING USED ON? ILIAC CREST.4. DID THE PHYSICIAN EXPERIENCE ANY DIFFICULTY INSERTING THE NEEDLE INTO THE PATIENT? NO DIFFICULTY INSERTING NEEDLE. PATIENT WAS (B)(6) YEAR OLD MALE.5. IS THE SAMPLE AVAILABLE FOR EVALUATION? PHYSICIAN PUT NEEDLE IN SHARPS CONTAINER. I WAS ABLE TO SAVE OUTER PACKAGE ONLY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
5147 JAMSHIDI BIOPSY NEEDLE KIT KNW CAREFUSION * 0000368256

Patients

Seq Age Sex Outcome Treatment
1 88 YR