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Description of Event or Problem

IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF NON-DEHP MICRO-VOLUME EXTENSION SETS LEAKED THROUGH THE AIR VENT HOLE. THE ISSUE OCCURRED WHEN THE LINE WAS PRIMED USING A PUMP OR MANUALLY WHEN THEY ARE CHANGING MEDICATIONS(IN PARTICULAR, SEDATION/ANALGESIA) OR FLUSHES. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

D4: UNIQUE DEVICE IDENTIFIER (UDI) # IS BASED ON THE DI INFORMATION AS NO LOT NUMBER WAS PROVIDED BY THE REPORTER. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO D9, H3, H6, AND H11: H11: THE DEVICE AND PHOTO SAMPLE WERE RECEIVED FOR EVALUATION. A VISUAL INSPECTION OF THE PHOTO SAMPLE WAS PERFORMED, AND A LEAK FROM THE FILTER WAS OBSERVED. VISUAL INSPECTION OF THE RETURNED SAMPLE DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. A PRESSURE TEST WAS PERFORMED, AND A LEAK IN THE AIR VENT OF THE FILTER WAS OBSERVED. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE WAS DETERMINED TO BE MANUFACTURING RELATED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.