BARD STATLOCK

Description of Event or Problem

IT WAS REPORTED THAT, "THE PRODUCT WHITE SECUREMENT APPEARS THINNER. THE WHITE SECUREMENT PART IS ACTUALLY DEGRADING AND WHEN THE PRIMARY DRESSING REMOVED AND BREAKING OFF IN PIECES, THE WHITE AREA DOESN¿T SEPARATE FROM THE PRIMARY DRESSING EITHER, AND ACTUALLY BREAKS DOWN TO A POINT THAT YOU HAVE TO TEAR AND TUG." A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

Additional Manufacturer Narrative

H11: THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE DATE OF EVENT WAS NOT PROVIDED BY THE COMPLAINANT/REPORTER, THE DATE REFLECTED IN THIS REPORT IS THE DATE BD BECAME AWARE OF THE EVENT. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.