GPS III SINGLE KIT W/30ML ACDA
Received Sep 9, 2016 · Event occurred Jan 13, 2015
Report 0001825034-2016-03569 · MDR key 5939349
Device
Generic name
Supplies, Blood-bank
Manufacturer
Biomet BiologicsModel number
N/ACatalog number
800-1003A
Lot number
402274
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Not reported
- Unspecified Infection
- No Information
- Unspecified Infection
- No Information
Narrative
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT AND RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, "DAMAGE TO BLOOD VESSELS, HEMATOMA, DELAYED WOUND HEALING AND/OR INFECTION." REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2.
Description of Event or Problem
DURING A SHOULDER ARTHROSCOPY PROCEDURE, A BLOOD PLATELET SEPARATION KIT WAS USED. THE PATIENT SUBSEQUENTLY DEVELOPED AN INFECTION. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Additional Manufacturer Narrative
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY.
Description of Event or Problem
DURING A SHOULDER ARTHROSCOPY PROCEDURE, AN UNKNOWN EVENT OCCURRED; IT IS INDICATED THE BLOOD PLATELET SEPARATION KIT WAS INVOLVED. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Remedial action
- Recall