Description of Event or Problem · 0
IT WAS REPORTED THAT A FOREIGN OBJECT, GLASS FRAGMENT, WAS EMBEDDED IN THE REAR SECTION OF THE MICROTEK PACEMAKER DRAPE (REF #PD201, LOT 4364LRO000). DURING THE DRAPING PROCESS IN THE CATHETERIZATION LABORATORY (CATH LAB), THE FRAGMENT MADE CONTACT WITH A RADIATION TECHNICIAN. THE GLASS WAS PARTIALLY PROTRUDING FROM THE FABRIC AND CAUSED A POKE TO THE TECHNICIAN. HOWEVER, THE CONTACT DID NOT RESULT IN SKIN PENETRATION, LACERATION, OR ANY REPORTABLE INJURY. THE INCIDENT WAS PROMPTLY DOCUMENTED BY THE REPORTER, AND PHOTOGRAPHIC EVIDENCE WAS COLLECTED TO SUPPORT THE COMPLAINT. NO PATIENT CONTACT OCCURRED, AND THERE WERE NO REPORTED INFECTIONS, COMPLICATIONS, OR ADVERSE CLINICAL OUTCOMES ASSOCIATED WITH THE EVENT. THE MANUFACTURER CONDUCTED AN INVESTIGATION BUT WAS UNABLE TO DETERMINE THE ORIGIN OF THE FOREIGN MATERIAL. NO ROOT CAUSE WAS IDENTIFIED.