PLASMAX MINI KIT W/30ML ACDA
Received May 15, 2018 · Event occurred Apr 18, 2018
Report 0001825034-2018-03368 · MDR key 7515685
Device
Generic name
Supplies, Blood-bank
Manufacturer
Zimmer Biomet, Inc.Model number
N/ACatalog number
800-0516
Lot number
NI
Product problems
- Fracture
- Fracture
Patient
Not reported
- No Code Available
- No Code Available
Narrative
Additional Manufacturer Narrative
(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DISCARDED.
Description of Event or Problem
IT WAS REPORTED THAT THE TIP OF THE SYRINGE BROKE OFF INTO THE PLASMAX TUBE. THE DEFECTIVE TUBE WAS THROWN AWAY IN BIOHAZARD. THERE WAS A 20 MINUTE DELAY BECAUSE THE PATIENT¿S BLOOD HAD TO BE REDRAWN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Additional Manufacturer Narrative
THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. THE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. PRODUCT NOT RETURNED.
Description of Event or Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.