N-C CONN TUBE 6MM X3.1M

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE MALE CONNECTOR ISN'T GLUED/ADHERING SO IT COMES OFF IN HAND. THERE WAS NO PATIENT HARM. PER ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2022, THE ISSUE OCCURRED DURING PATIENT USE. THE CONNECTOR WAS NOT LOOSE IN THE STERILE PACKAGING, PRIOR TO OPENING. THE EXACT DETAILS OF THE DETACHMENT ARE NOT KNOWN BUT THE CONNECTOR CAME OFF EITHER WHEN DISCONNECTING IT, MOVING THE TUBING E.G., TO MOVE IT UNDER A PILLOW, OR WHEN TRYING TO USE SUCTION DURING SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. THE DEVICE WAS MANUFACTURED ON JUNE 14, 2021. THERE WERE NO PHYSICAL SAMPLES OR PHOTOS PROVIDED FOR EVALUATION. BECAUSE A SAMPLE WAS NOT RETURNED, WE WERE UNABLE TO PERFORM A FOLLOW UP INVESTIGATION TO INCLUDE FUNCTIONAL AND VISUAL EVALUATIONS TO CONFIRM THE REPORTED ISSUE OR DETERMINE THE ROOT CAUSE. IF SAMPLES ARE RECEIVED AT A LATER DATE, THE COMPLAINT WILL BE REOPENED, AND THE INVESTIGATION WILL BE UPDATED ACCORDINGLY. A CORRECTIVE ACTION IS NOT APPLICABLE AT THIS TIME. FUNCTIONAL TESTING AND VISUAL INSPECTIONS ARE BEING PERFORMED ACCORDING TO OUR CURRENT QUALITY STANDARDS AND INSPECTION PROCEDURES. WE WILL CONTINUE TO MONITOR THE PROCESS, COMPLAINTS, AND FEEDBACK FOR ANY ADVERSE TRENDS THAT REQUIRE IMMEDIATE ATTENTION. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES. PLEASE DISCARD THE INVALID PHONE NUMBER PROVIDED IN SECTION E1 OF THE INITIAL REPORTER IN ERROR, THE REPORTER DID NOT PROVIDE THEIR PHONE NUMBER.;