GPS III SINGLE KIT W/30ML ACDA
Received Nov 28, 2016 · Event occurred Nov 21, 2016
Report 0001825034-2016-04886 · MDR key 6130945
Device
Generic name
Supplies, Blood-bank
Manufacturer
Biomet OrthopedicsModel number
NIN/ACatalog number
800-1003A
Lot number
NI
Product problems
- Inadequacy of Device Shape and/or Size
- Insufficient Device Problem Information
- Inadequacy of Device Shape and/or Size
- Insufficient Device Problem Information
Patient
Not reported
- Laceration(s)
- Laceration(s)
Narrative
Additional Manufacturer Narrative
THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS IS ONE OF TWO DEVICES THAT MAY HAVE BEEN INVOLVED IN THE EVENT.
Description of Event or Problem
PATIENT ALLEGED THE SIZE OF THE NEEDLE WAS LARGER THAN EXPECTED AND SHE SUSTAINED A LACERATION ON HER ARM AS A RESULT.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. A DEFINITE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION 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.