JAMSHIDI NEEDLE BONE MARROW 11GX4 ASP

Additional Manufacturer Narrative

(B)(4) IF FURTHER INFORMATION BECOME AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

Additional Manufacturer Narrative

(B)(4). PICTURES OF THE ACTUAL UNIT WERE RECEIVED. WHILE ANALYZING THE PICTURES, IT WAS NOTICED THAT THE NEEDLE WAS BROKEN. FAILURE MODE COULD BE CONFIRMED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORD FOR THE REPORTED LOT NUMBER WAS PERFORMED AND IT WAS CONFIRMED THAT PROCEDURAL AND FUNCTIONAL REQUIREMENTS NEEDED FOR ITS RELEASE WERE MET. ALSO, A REVIEW OF THE DEVICE¿S COMPONENTS HISTORY RECORD REVIEW WAS PERFORMED AND NO ISSUES WERE FOUND. IT IS NOT CONSIDERED PERSONNEL COULD BE RELATED TO FAILURE MODE REPORTED SINCE NO ISSUES WERE FOUND DURING APPLICABLE MANUFACTURING PROCESS AND TRAINING RECORDS ANALYSIS THAT COULD RELATE PERSONNEL TO THE REPORTED FAILURE. NO ISSUES RELATED TO EQUIPMENT/MACHINE WERE FOUND DURING THE INVESTIGATION THAT COULD RELATE IT TO THE REPORTED FAILURE MODE. DURING THE INVESTIGATION, A REVIEW OF ENVIRONMENT SPECIFICATIONS, PROCEDURES AND MONITORING DATA DID NOT FIND ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. MOST PROBABLE ROOT CAUSE COULD BE RELATED TO MATERIAL PROVIDED BY THE SUPPLIER. A SUPPLIER CORRECTIVE ACTION REQUEST HAS BEEN OPENED REGARDING BROKEN DJ NEEDLE.

Description of Event or Problem

MEDICAL SPECIALTIES - FELL APART. PER NURSE MANAGER,  PATIENT WAS HAVING A BONE BIOPSY AND PHYSICIAN FELT SOMETHING HAPPEN WITH NEEDLE AND STOPPED PROCEDURE. THE NEEDLE WAS NOT ABLE TO BE EXTRACTED, ORTHOPEDIC SURGEON CONSULTED PATIENT AND WAS NOT ABLE TO RETRIEVE BROKEN NEEDLE. THE PATIENT WAS SEEN BY ORTHOPEDIC SURGEON, NEEDLE UNABLE TO BE EXTRACTED FROM PATIENT. CT SCAN PERFORMED. NEEDLE REMAINS IN PATIENT¿S HIP. PATIENT FOLLOWED BY PHYSICIAN TO MONITOR.