DAVOL® FEMALE CATH KIT

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTIONS A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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.

Description of Event or Problem

IT WAS REPORTED THAT THE FEMALE CATHETER THAT GOES INTO THE PATIENT WAS VERY LOOSE/SLIDING OUT OF THE HOLDER INSERTING OR GOING BACK INTO THE HOLDER INSTEAD OF INTO THE PATIENT. CLINIC HAD 2 LIKE THIS BUT MANAGED TO HOLD THEM IN ORDER TO USE THEM.