RAPIDLYTE 3 ML L/S SYRINGE FILTER CAP

Additional Manufacturer Narrative

INVESTIGATION COMPLETED: REVIEW OF MANUFACTURING RECORDS FOR LOT # 3673346 REVEALED NO DISCREPANCIES OR ANOMALIES. A TOTAL OF THREE USED SYRINGES WERE RECEIVED FOR ANALYSIS. NO ORIGINAL PACKAGING WAS RETURNED. VISUAL EXAMINATION OF THE SYRINGES REVEALED HOLES IN THE MOLDING GATES OF TWO SYRINGE BARRELS. A SIMILAR HOLE WAS FOUND IN THE SHOULDER OF THE THIRD SYRINGE'S BARREL. IN RESPONSE TO THESE OBSERVATIONS, NOTIFICATIONS WERE PROVIDED TO THE SUPPLIER FOR THE SYRINGE BARREL COMPONENT AS WELL AS THE MANUFACTURER'S PERSONNEL. COMPLAINT DATA WILL CONTINUE TO BE MONITORED FOR NEW INFORMATION, WITH FURTHER ACTIONS TAKEN ACCORDINGLY.

Additional Manufacturer Narrative

(B)(6) 2019: UPDATE: BIOHAZARD PACKAGING IS REQUIRED FOR THE SYRINGES TO BE SENT TO THE SUPPLIER FOR INVESTIGATION. THE CONTAINERS THAT WERE SHIPPED WERE TOO SMALL FOR THE USED SYRINGES. SIEMENS IS WAITING FOR THE LARGER CONTAINERS TO BE SENT.

Additional Manufacturer Narrative

SIEMENS HAS REQUESTED THE SYRINGES BE PROVIDED FOR INVESTIGATION. THE CUSTOMER STATED THAT THE OPERATOR WASHED THEIR EYES WITH EYE WASH SOLUTION AND DID NOT SEEK MEDICAL INTERVENTION.

Description of Event or Problem

THE CUSTOMER REPORTED THAT A RAPIDLYTE 3 ML L/S SYRINGE SPRAYED BLOOD WHILE ASPIRATING A SAMPLE. THE BLOOD SPRAYED IN THE OPERATOR'S EYE. THE OPERATOR WAS NOT WEARING SAFETY GLASSES.

Additional Manufacturer Narrative

(B)(6) 2019: UPDATE: THE SUPPLIER HAS INDICATED THERE WAS A CLEARANCE DELAY THAT DELAYED THE INVESTIGATION. THE SHIPMENT HAS NOW BEEN RELEASED AND IS ON ITS WAY TO THE INVESTIGATION SITE.