INTERLINK

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO D1, D2A, D2B, D4, D9, H3, H6, AND H11: H11: THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED, AND THE SEPTUM OF THE Y-SITE WAS ABNORMALLY ASSEMBLED. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE WAS DETERMINED TO BE FROM MANUFACTURING. 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 THE NEEDLE ACCESS POINT OF A MICRO-VOLUME EXTENSION SET HAD A DEFECTIVE RUBBER PORTION AND LEAKED. THIS WAS OBSERVED DURING USE. A PEDI PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) WAS USED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.