| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SURESTEP FOLEY TRAY - LUBRICATH | CATHETER | BARD SDN. BHD. -8040607 | EZC | A800361 | 4NN9096 | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-12-07 | 0 |
Patient 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF 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 BARD.
Patient 1
IT WAS REPORTED THAT A SPLIT WAS NOTED IN THE CATHETER BALLOON. PRIOR TO SURGERY, THE FOLEY CATHETER (CONTAINED IN THE SURE STEP TRAY (16FR)), WAS INSERTED AND THE BALLOON WAS INFLATED SUCCESSFULLY. THE CATHETER PERFORMED PROPERLY (DRAINING URINE) THROUGHOUT THE SURGICAL CASE. AT THE END OF THE SURGERY, THE CATHETER FELL OUT, AND WAS NOTED TO HAVE AN ALLEGED ?SPLIT? IN THE BALLOON MATERIAL. THE BALLOON APPEARED TO HAVE A ?CLEAN SLIT?, AND NO MISSING PIECES WERE NOTED.
Patient 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF 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 BARD.
Patient 1
IT WAS REPORTED THAT A SPLIT WAS NOTED IN THE CATHETER BALLOON. PRIOR TO SURGERY, THE FOLEY CATHETER (CONTAINED IN THE SURE STEP TRAY (16FR)), WAS INSERTED AND THE BALLOON WAS INFLATED SUCCESSFULLY. THE CATHETER PERFORMED PROPERLY (DRAINING URINE) THROUGHOUT THE SURGICAL CASE. AT THE END OF THE SURGERY, THE CATHETER FELL OUT, AND WAS NOTED TO HAVE AN ALLEGED ?SPLIT? IN THE BALLOON MATERIAL. THE BALLOON APPEARED TO HAVE A ?CLEAN SLIT?, AND NO MISSING PIECES WERE NOTED.
Patient 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF 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 BARD.
Patient 1
IT WAS REPORTED THAT A SPLIT WAS NOTED IN THE CATHETER BALLOON. PRIOR TO SURGERY, THE FOLEY CATHETER (CONTAINED IN THE SURE STEP TRAY (16FR)), WAS INSERTED AND THE BALLOON WAS INFLATED SUCCESSFULLY. THE CATHETER PERFORMED PROPERLY (DRAINING URINE) THROUGHOUT THE SURGICAL CASE. AT THE END OF THE SURGERY, THE CATHETER FELL OUT, AND WAS NOTED TO HAVE AN ALLEGED ?SPLIT? IN THE BALLOON MATERIAL. THE BALLOON APPEARED TO HAVE A ?CLEAN SLIT?, AND NO MISSING PIECES WERE NOTED.
Patient 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF 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 BARD.
Patient 1
IT WAS REPORTED THAT A SPLIT WAS NOTED IN THE CATHETER BALLOON. PRIOR TO SURGERY, THE FOLEY CATHETER (CONTAINED IN THE SURE STEP TRAY (16FR)), WAS INSERTED, AND THE BALLOON WAS INFLATED SUCCESSFULLY. THE CATHETER PERFORMED PROPERLY (DRAINING URINE) THROUGHOUT THE SURGICAL CASE. AT THE END OF THE SURGERY, THE CATHETER FELL OUT, AND WAS NOTED TO HAVE AN ALLEGED ?SPLIT? IN THE BALLOON MATERIAL. THE BALLOON APPEARED TO HAVE A ?CLEAN SLIT?, AND NO MISSING PIECES WERE NOTED.
Patient 1
RECEIVED 1 USED FOLEY CATHETER. THE VISUAL INSPECTION NOTED AN IRREGULAR BALLOON BURST. HOWEVER, THERE WERE NO PIECES OF THE SAC MISSING. PER THE FUNCTIONAL TESTING, WATER WAS INTRODUCED INTO THE INFLATION LUMEN AND NO OBSTRUCTIONS TO IMPEDE FLOW WERE EXPERIENCED. MICROSCOPIC EXAMINATION FOUND NO CONDITIONS THAT COULD BE ASSOCIATED WITH THE REPORTED EVENT. THE DIMENSIONAL EVALUATION RESULTS WERE AS FOLLOWS: EYE SNIP LENGTH: 3/32?, INFLATION LUMEN COVERAGE: 10 THOU, BALLOON THICKNESS: 21 THOU, BURST INITIATED FROM BOTTOM COLLAR OF SAC: 5MM. PER THE TACTILE EVALUATION, THE BALLOON'S THICKNESS MEASURED AN AVERAGE OF 21 THOU. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "DO NOT USE OINTMENTS OR LUBRICANTS HAVING A PETROLATUM BASE. THEY WILL DAMAGE LATEX AND MAY BURST BALLOON." (B)(4). THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF 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 BARD.
Patient 1
IT WAS REPORTED THAT A SPLIT WAS NOTED IN THE CATHETER BALLOON. PRIOR TO SURGERY, THE FOLEY CATHETER (CONTAINED IN THE SURE STEP TRAY (16FR)), WAS INSERTED, AND THE BALLOON WAS INFLATED SUCCESSFULLY. THE CATHETER PERFORMED PROPERLY (DRAINING URINE) THROUGHOUT THE SURGICAL CASE. AT THE END OF THE SURGERY, THE CATHETER FELL OUT, AND WAS NOTED TO HAVE AN ALLEGED ?SPLIT? IN THE BALLOON MATERIAL. THE BALLOON APPEARED TO HAVE A ?CLEAN SLIT?, AND NO MISSING PIECES WERE NOTED.