UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER

Additional Manufacturer Narrative

POSTAL CODE: (B)(6), PHONE NUMBER: (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. NO PATIENT HARM WAS REPORTED FOR THIS COMPLAINT. NO LOT NUMBER OR PRODUCT EVALUATION SAMPLE IS AVAILABLE, A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS EVALUATION WILL BE CLOSED AND WILL BE MONITORED THROUGH OUR POST MARKET PRODUCT MONITORING REVIEW PROCESS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

COMPLAINT RECEIVED FROM A HEALTHCARE PROFESSIONAL REPORTING A PHYSICAL INTEGRITY ISSUE WITH THE DEVICE AFTER A "FEW DAYS" OF PATIENT USE. REPORTER STATED "THE MIDDLE OF THE COLLECTION CHAMBER IS BROKEN DURING USE, AND THEREBY THE COLLECTING CHAMBER CAN BE DISASSEMBLED AND IT IS THEREBY LEAKING. COLLECTION CHAMBER BREAKING DURING USE. WHEN OPENED OR CLOSED, THE CHAMBER MAY BREAK AND COME APART. THE CONSEQUENCE IS THAT THE SYSTEM IS LEAKING AND FLOWING URINE ALL OVER THE PLACE." THE REPORTER PROVIDED NO PATIENT DETAILS, BUT STATED THE DEVICE WAS CHANGED TO A NEW ONE. PHOTOS PROVIDED BY THE REPORTER SHOW THE INLET TUBING AND OPEN/CLOSE LEVEL HAVE DETACHED FROM THE CHAMBER. THE REPORTER STATED THAT THE DEVICE IS NOT AVAILABLE FOR RETURN.