TRAY BONANNO CATHETER S/SU

Additional Manufacturer Narrative

INVESTIGATION: BD HAS BEEN PROVIDED WITH 2 SAMPLES FOR CATALOG 408289 TO INVESTIGATE FOR THIS RECORD. SAMPLE RECEIVED WAS NOT THE ACTUAL SAMPLE INVOLVED IN THE REPORTED COMPLAINT. IT WAS A REPRESENTATIVE SAMPLE FROM THE LOT 8008682 REPORTED IN THIS COMPLAINT. IT WAS ALSO RECEIVED IN THE SAME PACKAGE ANOTHER SAMPLE FROM A DIFFERENT LOT 7137953. TWO SAMPLES WERE RECEIVED, JUST ONE A REPRESENTATIVE SAMPLE OF THE LOT REPORTED IN THE COMPLAINT. UNFORTUNATELY, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE AS NO MALFUNCTIONS OR NON-CONFORMANCE'S WERE IDENTIFIED WHEN TESTED BY THE QC INSPECTORS. WITH THE INFORMATION PROVIDED, THE MOST PROBABLE ROOT CAUSE IS AN INCORRECT USE OF THE MATERIAL. AS PER DHR REVIEW THERE WERE NO ISSUES REPORTED THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO NCMRS WERE GENERATED FOR THIS BATCH. NO PREVIOUS HISTORY OF COMPLAINTS RELATED TO TRAY BONANNO CATHETER WERE IDENTIFIED.

Description of Event or Problem

IT WAS REPORTED THAT A BROKEN CATHETER OCCURRED DURING USE WITH A TRAY BONANNO CATHETER S/SU. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CNM INFORMED ME THAT A SENIOR REGISTER WAS DOING AN ABDOMINAL TAP TO REMOVE FLUID FROM PATIENT ABDOMINAL WHEN THE CATHETER KINKED. TRIED 2ND CATHETER AND TIP BROKE OFF. ALL OFF DEVICE RETRIEVED FROM PATIENT."

Additional Manufacturer Narrative

A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT A BROKEN CATHETER OCCURRED DURING USE WITH A TRAY BONANNO CATHETER S/SU. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CNM INFORMED ME THAT A SENIOR REGISTER WAS DOING AN ABDOMINAL TAP TO REMOVE FLUID FROM PATIENT ABDOMINAL WHEN THE CATHETER KINKED. TRIED 2ND CATHETER AND TIP BROKE OFF. ALL OFF DEVICE RETRIEVED FROM PATIENT."