BIOPSY TRAY SOFT TISSUE W/O NEEDLE
Received Oct 5, 2015 · Event occurred Sep 9, 2015
Report 1625685-2015-00217 · MDR key 5128474
Device
Product problems
- Structural Problem
Patient
Not reported
- Bacterial Infection
- Needle Stick/Puncture
Narrative
Additional Manufacturer Narrative
(B)(4). ONE FOAM NEEDLE STOP WAS RETURNED FOR ANALYSIS. THE PLASTIC TRAY TO WHICH THE STOP IS ATTACHED WAS CUT SO THAT ONLY THE SECTION IN QUESTION WAS RETURNED. THE PLASTIC SURROUNDING THE FOAM STOP SAMPLE WAS VISUALLY INSPECTED FOR A PUNCTURE, AND NO DEFECT WAS FOUND. (B)(4). NO ADVERSE TREND WAS DETECTED. SAMPLE ANALYSIS COULD NOT CONFIRM THE REPORTED FAILURE MODE. A LOT NUMBER FOR THE PRODUCT WAS NOT PROVIDED WITH THE COMPLAINT, SO THE DEVICE HISTORY COULD NOT BE INVESTIGATED. TRENDING DATA FOR THE REPORTED FAILURE DID NOT INDICATE A NEGATIVE TREND. THEREFORE, A ROOT CAUSE COULD NOT BE ESTABLISHED. IN ADDITION: THE VERBATIM OF THE CUSTOMER INDICATES THAT THE TRAY HAD HISTORICALLY BEEN USED TO ASSIST THE FOAM NEEDLE STOP IN PREVENTING INJURY. PLEASE KNOW THE INTENDED USE OF THE TRAY IS STRICTLY FOR CONTAINING THE CONTENTS, NOT PREVENTING INJURY.
Additional Manufacturer Narrative
(B)(4). UPON CAREFUSIONS INVESTIGATION, A FOLLOW UP EMDR SUBMISSION WILL BE DONE.
Description of Event or Problem
NEEDLE STICK NEEDLE USING OUR FOAM NEEDLE STOP. HE INDICATES THAT THE PLASTIC SURROUNDING THE FOAM IS THINNER THAN IN THE PAST AND INSUFFICIENT TO PREVENT INJURY. IT WAS CONFIRMED THAT THE DOCTOR WAS HARMED. (B)(6) 2015 ADDITIONAL RESPONSE-THE NEEDLE WAS CONTAMINATED THEREFORE PROVIDER REQUIRED POST NEEDLE STICK BLOOD DRAW, HE SUFFERS FROM NO HEALTH CHANGES AT THIS TIME LOT NUMBER IS NOT AVAILABLE HOWEVER NEEDLE HOLDER IS.