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 LEAK. A PRESSURE TEST WAS PERFORMED ON THE SAMPLE, AND A LEAK WAS OBSERVED IN THE AIR VENT OF THE FILTER. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. 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.

Description of Event or Problem

IT WAS REPORTED THAT A NON-DEHP MICRO-VOLUME EXTENSION SET WAS CRACKED AND LEAKED AT THE CIRCULAR FILTER OF THE LINE CONNECTED TO THE INTERNAL JUGULAR CATHETER PORT. NO OTHER MEDICATIONS WERE RUNNING THROUGH THE PORT DUE TO ACCESS AVAILABILITY FOR DRIPS AND ALPROSTADIL AND TPN (TOTAL PARENTERAL NUTRITION) LIPIDS. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

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