| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | BARDEX I.C. 5CC LATEX FOLEY CATHETER WITH SILVER/HYDROGEL COATING,2-WAY, | LATEX FOLEY CATHETER | BARD SDN. BHD. -8040607 | MJC | 0165SI14 | 6DM5035 | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-01-31 | 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 THE CATHETER WAS LEAKING.
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 THE CATHETER WAS LEAKING.
Patient 1
RECEIVED 1 USED FOLEY CATHETER WITH THE DRAINAGE BAG STILL ATTACHED AND THE ORIGINAL UNIT LABELING. PER THE VISUAL INSPECTION, THE EXTERIOR OF THE SAMPLE WAS INSPECTED AND DID NOT FIND ANY EVIDENCE OF A FAILURE THAT WOULD SUPPORT THE REPORTED EVENT. DURING THE FUNCTIONAL TESTING, THE SAMPLE WAS EXAMINED AND DID NOT FIND ANY HOLES, RIPS OR TEARS. INTRODUCED WATER INTO THE DRAINAGE EYE AND DID NOT FIND ANY LEAKAGE FROM THE DISTAL END OF THE SAMPLE. INFLATED BALLOON WITH AIR WHILE SUBMERGED IN WATER AND THERE WERE NO BUBBLES TO INDICATE A LEAK . TESTED FLOW RATE WHILE BALLOON WAS INFLATED WITH 10CC WATER AND FOUND THE FLOW TO BE 400ML/MIN, 400ML/MIN AND 400ML/MIN. THE INTERNAL FLOW RATE SPECIFICATION FOR A SAMPLE OF THIS PRODUCT TYPE IS 100ML/MIN MINIMUM, SO THE SAMPLE DID MEET THE INTERNAL SPECIFICATIONS. INFLATED BALLOON AND FOUND CONCENTRICITY TO BE 60:40. THE INTERNAL CONCENTRICITY SPECIFICATION FOR A SAMPLE OF THIS PRODUCT TYPE IS 70:30 MAXIMUM, SO THE SAMPLE MEETS THE CONCENTRICITY SPECIFICATION. INFLATED WITH 10CC OF WATER AND PERFORMED LEAK TEST. ON THE SEVENTH DAY, THE BALLOON WAS FULLY INFLATED WITH NO SIGNS OF LEAKING. PER THE DIMENSIONAL EVALUATION, THE SHAFT OF THE CATHETER WAS MEASURED AND FOUND THAT THE CATHETER WAS MANUFACTURED WITHIN THE SPECIFICATION. THE SHAFT MEASUREMENT - 16.9FR (WITHIN SPECIFICATION). 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: "VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. IF PACKAGE IS OPENED OR IF ANY IMPERFECTION OR SURFACE DETERIORATION IS OBSERVED, DO NOT USE." (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 THE CATHETER WAS LEAKING.