HYDROMARK

Additional Manufacturer Narrative

UPON RECEIPT OF MMT'S RECALL NOTICE, THE ACCOUNT DISCOVERED THAT THEY HAVE TWO BOXES OF THE THE RECALLED LOT. ONE BOX IS FULL AND ONE BOX IS MISSING 5 MARKERS. THE ACCOUNT CANNOT CONFIRM THAT THE 5 MARKERS WERE USED ON PATIENTS AS THEY DO NOT HAVE A SYSTEM TO DOUBLE CHECK SPECIFIC TYPES OF MARKERS THAT WERE USED. NO PATIENT COMPLICATIONS WERE REPORTED. AFTER REACHING OUT TO THE CUSTOMER, IT WAS CONFIRMED STANDARD PRACTICE AT THE FACILITY IS TO PERFORM POST PROCEDURE IMAGING AND CONFIRM THE PRESENCE OF THE CLIP IN THE MEDICAL RECORD, HOWEVER, THEY DO NOT DOCUMENT THE SHAPE OF THE CLIP OR TYPE OF CLIP IE T3, T4 IN THE REPORT. A RECALL WAS INITIATED (RES# 98843). CUSTOMERS WHO RECIEVED THIS IMPACTED LOT HAVE BEEN NOTIFIED AND WERE ADVISED TO UPDATE PATIENT RECORDS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS INCIDENT. WE ARE REPORTING THIS INCIDENT SINCE TO DATE WE HAVE NOT BEEN ABLE TO CONFIRM THE PATIENT RECORDS HAVE BEEN UPDATED WITH THE CORRECT MARKER SHAPE.

Description of Event or Problem

UPON RECEIPT OF MMT'S RECALL NOTICE, THE ACCOUNT DISCOVERED THAT THEY HAVE TWO BOXES OF THE THE RECALLED LOT. ONE BOX IS FULL AND ONE BOX IS MISSING 5 MARKERS. THE ACCOUNT CANNOT CONFIRM THAT THE 5 MARKERS WERE USED ON PATIENTS AS THEY DO NOT HAVE A SYSTEM TO DOUBLE CHECK SPECIFIC TYPES OF MARKERS THAT WERE USED. NO PATIENT COMPLICATIONS WERE NOTED.