DAVOL® FEMALE CATH KIT

Description of Event or Problem

IT WAS REPORTED THAT THE HOSPITAL USER STATED THAT THEY WERE GIVEN THE PACKAGE OF A DEFECTIVE BARD FEMALE CATHETER KIT 8 FR., SKU 0035720 FROM THEIR EMERGENCY DEPARTMENT. THEY MENTIONED THAT THE CATHETER TUBE WAS BROKEN IN HALF, BUT THEY DID NOT KEEP THE PRODUCT.

Additional Manufacturer Narrative

THE INITIAL REPORTER'S LAST NAME: (B)(6). 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.

Additional Manufacturer Narrative

THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. A LABELING REVIEW IS NOT REQUIRED BECAUSE LABELING COULD NOT HAVE PREVENTED THE REPORTED ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME. CORRECTION: D. 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 HOSPITAL USER STATED THAT THEY WERE GIVEN THE PACKAGE OF A DEFECTIVE BARD FEMALE CATHETER KIT 8 FR., SKU 0035720 FROM THEIR EMERGENCY DEPARTMENT. THEY MENTIONED THAT THE CATHETER TUBE WAS BROKEN IN HALF, BUT THEY DID NOT KEEP THE PRODUCT.