DAVOL® PEDIATRIC CATH KIT

Additional Manufacturer Narrative

OUR TEAM CONDUCTED A REVIEW OF THE REPORTED EVENT, WITH THE AVAILABLE INFORMATION TO ENSURE THE ONGOING SAFETY AND PERFORMANCE OF THE PRODUCT. AS THIS INVESTIGATION HAS ALREADY BEEN PERFORMED FOR A SIMILAR COMPLAINT, ANOTHER INVESTIGATION IS NOT NECESSARY. AN INVESTIGATION HAS BEEN COMPLETED USING ALL INFORMATION CURRENTLY AVAILABLE. IT REPRESENTS A KNOWN FAILURE MODE THAT HAS BEEN ASSESSED IN THE PRODUCT RISK MANAGEMENT FILE IN ACCORDANCE WITH APPLICABLE REGULATORY STANDARDS AND INTERNAL PROCEDURES. THE ASSOCIATED RISKS CONTINUE TO BE MONITORED AS PART OF ONGOING POST MARKET ACTIVITIES IN COMPLIANCE WITH BOTH REGULATORY REQUIREMENTS AND LOCAL PROCEDURES.CORRECTIONS: D, EUDI 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 AN 8 FRENCH PEDIATRIC STRAIGHT CATHETER KIT HAD BEEN OPENED TO OBTAIN A URINE SAMPLE FROM THE PATIENT. THE CATHETER, WHICH SHOULD HAVE REMAINED SECURED IN THE COLLECTION TUBE UNTIL MANUALLY PULLED OUT, HAD BEEN LOOSE AND HAD FALLEN OUT OF THE COLLECTION TUBE DURING THE PROCEDURE. ANOTHER NURSE WHO HAD BEEN ASSISTING WITH HOLDING THE PATIENT HAD HELPED STABILIZE THE TUBE TO MAINTAIN STERILITY. NO HARM HAD REACHED THE PATIENT; HOWEVER, THE ISSUE HAD RESULTED IN AWKWARD POSITIONING AND A SLOWER PROCEDURE. TWO MORE 8 FRENCH PEDIATRIC STRAIGHT CATHETER KITS WITH THE SAME LOT NUMBER HAD BEEN OPENED. ONE HAD ALSO BEEN LOOSE, WITH THE CATHETER SLIPPING OUT OF THE COLLECTION TUBE, WHILE THE OTHER HAD SHOWN SOME RESISTANCE AND HAD NOT FALLEN OUT AS EASILY.

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. SECTION 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 AN 8 FRENCH PEDIATRIC STRAIGHT CATHETER KIT HAD BEEN OPENED TO OBTAIN A URINE SAMPLE FROM THE PATIENT. THE CATHETER, WHICH SHOULD HAVE REMAINED SECURED IN THE COLLECTION TUBE UNTIL MANUALLY PULLED OUT, HAD BEEN LOOSE AND HAD FALLEN OUT OF THE COLLECTION TUBE DURING THE PROCEDURE. ANOTHER NURSE WHO HAD BEEN ASSISTING WITH HOLDING THE PATIENT HAD HELPED STABILIZE THE TUBE TO MAINTAIN STERILITY. NO HARM HAD REACHED THE PATIENT; HOWEVER, THE ISSUE HAD RESULTED IN AWKWARD POSITIONING AND A SLOWER PROCEDURE. TWO MORE 8 FRENCH PEDIATRIC STRAIGHT CATHETER KITS WITH THE SAME LOT NUMBER HAD BEEN OPENED. ONE HAD ALSO BEEN LOOSE, WITH THE CATHETER SLIPPING OUT OF THE COLLECTION TUBE, WHILE THE OTHER HAD SHOWN SOME RESISTANCE AND HAD NOT FALLEN OUT AS EASILY.