MICRO-VOLUME EXTENSION SET

Additional Manufacturer Narrative

H10: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. FUNCTIONAL PRESSURE TEST AND CLEAR PASSAGE TESTS WERE PERFORMED; NO LEAK AND BLOCKAGE WERE IDENTIFIED. THE REPORTED CONDITION WAS NOT VERIFIED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A NON-DEHP MICRO-VOLUME EXTENSION SET LEAKED FROM THE FILTER. THE SET WAS CONNECTED TO AN UPPER EXTREMITY PEDIATRIC PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) LINE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.