STATLOCK PICC PLUS CRESCENT SLIDING POST

Additional Manufacturer Narrative

THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF JUDZ1473 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

Description of Event or Problem

IT WAS REPORTED "AN END USER REPORTED THAT AN ISSUE WAS EXPERIENCED WITH THE STATLOCK OF THIS BIOSTABLE PICC. PRIOR TO PLACING THE STATLOCK, A "SKIN-PREP" FROM SMITH & NEPHEW WAS USED ON THE PATIENT'S UPPER ARM AND THE SKIN PREP WAS ALLOWED TO DRY PROPERLY. DURING PROCEDURE CLOSURE, THE POST ON THE LEFT SIDE WAS NOT STICKING, WHICH HAS BECOME A PROBLEM. TAPE WAS USED TO SECURE THE DEVICE; HOWEVER, THIS RESULTED IN BLEEDING AT THE SITE AND AN INCREASE IN PROCEDURE TIME. THERE WAS NO SERIOUS HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT."