STANDARD BINDER LIFT 2.0

Additional Manufacturer Narrative

CUSTOMER FOUND NO OTHER ISSUES IN THE SAME LOT. REPLACEMENT STRAPS WERE SHIPPED FOR THE AFFECTED DEVICE. BOTH THE CONTRACT MANUFACTURER AND PHASE INSPECTED ALL INVENTORY; NO FURTHER DEFECTS WERE IDENTIFIED. THE ISSUE WAS ISOLATED TO A SINGLE DEVICE.

Description of Event or Problem

THE BINDER LIFT TRANSFER AID CONSISTS OF A TORSO WRAP WITH FULLY REMOVABLE LEG STRAPS. EACH LEG STRAP IS DESIGNED TO BUCKLE INTO BOTH THE FRONT AND BACK OF THE TORSO WRAP, WITH THE MALE BUCKLE ATTACHED TO THE LEG STRAP AND THE FEMALE BUCKLE ATTACHED TO THE TORSO WRAP. DURING USE OF A DEVICE FROM LOT NUMBER RFI-041625-S2 (UDI: (B)(4), PRODUCT CODE: S2-BL), ONE LEG STRAP MALFUNCTIONED BECAUSE THE STITCHING THAT ATTACHES THE STRAP TO ITS MALE BUCKLE WAS MISSING. WITHOUT THIS STITCHING, THE MALE BUCKLE DETACHED FROM THE STRAP AND COULD NOT PROPERLY CONNECT TO THE FEMALE BUCKLE ON THE TORSO WRAP. THE STRAP FAILURE WAS OBSERVED MID-USE, BUT THE TRANSFER LIFT ASSIST WAS COMPLETED SUCCESSFULLY. NO PATIENT HARM OCCURRED, AND NO CLINICAL SIGNS, SYMPTOMS, OR CONDITIONS WERE REPORTED. THE INCIDENT RESULTED IN NO HEALTH CONSEQUENCES OR IMPACT.