| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | BARD DISPOZ-A-BAG LEG BAG WITH FLIP-FLO DRAINAGE VALVE, FABRIC STRAPS | TUBE | PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 | FAQ | 150719 | NGZK4764 | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-12-08 | 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. THE DEVICE WAS NOT RETURNED.
Patient 1
IT WAS REPORTED THAT KINKING IN THE TUBING OBSTRUCTED URINE. AS A RESULT, URINE DID NOT FLOW PROPERLY WHICH POTENTIALLY CAUSED BACKFLOW. THE HEALTHCARE PROFESSIONAL EXPLAINED THAT THE KINK MAY BE FROM BEING STORED TOO LONG. IT WAS ALSO REPORTED THAT THE RUBBER CONNECTION (PLIABLE SQUASH, KINK AND BEND) COULD RESTRICT FLOW AS WELL. THERE WAS NO REPORTED PATIENT INJURY AND NO URINE RETENTION.
Patient 1
THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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: "WARNING: DO NOT USE OINTMENTS OR LUBRICANTS HAVING A PETROLATUM BASE. THEY WILL DAMAGE THE CATHETER. VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. USE LUER TIP SYRINGE TO INFLATE WITH STATED ML OF STERILE WATER. OR FOR PRE-FILLED PRODUCTS, REMOVE CLIP AND SQUEEZE RESERVOIR TO INFLATE WITH STATED ML OF STERILE WATER. FOR UROLOGICAL USE ONLY. TO DEFLATE CATHETER BALLOON: GENTLY INSERT A LUER SLIP TIP SYRINGE IN THE CATHETER VALVE. NEVER USE MORE FORCE THAN IS REQUIRED TO MAKE THE SYRINGE ?STICK? IN THE VALVE. ALLOW THE PRESSURE WITHIN THE BALLOON TO FORCE THE PLUNGER BACK AND FILL THE SYRINGE WITH WATER. IF YOU NOTICE SLOW OR NO DEFLATION, RE-SEAT THE SYRINGE GENTLY. USE ONLY GENTLE ASPIRATION TO ENCOURAGE DEFLATION IF NEEDED. VIGOROUS ASPIRATION MAY COLLAPSE THE INFLATION LUMEN, PREVENTING BALLOON DEFLATION. IF NECESSARY, CONTACT ADEQUATELY TRAINED PROFESSIONAL FOR ASSISTANCE, AS DIRECTED BY HOSPITAL PROTOCOL. SHOULD BALLOON RUPTURE OCCUR, CARE SHOULD BE TAKEN TO ASSURE THAT ALL BALLOON FRAGMENTS HAVE BEEN REMOVED FROM THE PATIENT. A NEW CONNECTOR WITH A NEEDLE FREE SAMPLE PORT HAS BEEN ADDED TO THIS PRODUCT. INSTRUCTIONS FOR USE FOR THE NEEDLE-FREE SAMPLING: KINK THE DRAINAGE TUBING AT A MINIMUM OF 5CM BELOW THE SAMPLING PORT. WIPE THE SURFACE OF THE PORT WITH AN ALCOHOL SWAB. USING AN ASEPTIC TECHNIQUE, POSITION THE SYRINGE (LUER SLIP TIP ONLY) IN THE CENTER, PERPENDICULAR TO THE SURFACE OF THE PORT, AND THEN PRESS THE TIP OF THE SYRINGE INTO THE SAMPLING PORT. ASPIRATE THE DESIRED VOLUME AND THEN REMOVE THE SYRINGE. WIPE THE SURFACE OF THE PORT WITH AN ALCOHOL SWAB. UNKINK THE TUBING AND SEND THE CORRECTLY LABELED SPECIMEN TO THE LABORATORY." (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. THE DEVICE WAS NOT RETURNED.
Patient 1
IT WAS REPORTED THAT KINKING IN THE TUBING OBSTRUCTED URINE. AS A RESULT, URINE DID NOT FLOW PROPERLY WHICH POTENTIALLY CAUSED BACKFLOW. THE HEALTHCARE PROFESSIONAL EXPLAINED THAT THE KINK MAY BE FROM BEING STORED TOO LONG. IT WAS ALSO REPORTED THAT THE RUBBER CONNECTION (PLIABLE SQUASH, KINK AND BEND) COULD RESTRICT FLOW AS WELL. THERE WAS NO REPORTED PATIENT INJURY AND NO URINE RETENTION.
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 KINKING IN THE TUBING OBSTRUCTED URINE. AS A RESULT, URINE DID NOT FLOW PROPERLY WHICH POTENTIALLY CAUSED BACKFLOW. THE HEALTHCARE PROFESSIONAL EXPLAINED THAT THE KINK MAY HAVE BEEN FROM BEING STORED TOO LONG. IT WAS ALSO REPORTED THAT THE RUBBER CONNECTION (PLIABLE SQUASH, KINK AND BEND) COULD RESTRICT FLOW AS WELL. THERE WAS NO REPORTED PATIENT INJURY AND NO URINE RETENTION.
Patient 1
RECEIVED 2 UNOPENED LEG BAGS. DURING THE VISUAL INSPECTION, NO OBVIOUS DEFECTS WERE NOTED IN THE SAMPLES. THE REPORTED ISSUE WAS UNCONFIRMED DUE TO THE PROBLEM COULD NOT BE REPRODUCED. 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: "WARNING: DO NOT USE OINTMENTS OR LUBRICANTS HAVING A PETROLATUM BASE. THEY WILL DAMAGE THE CATHETER. VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. USE LUER TIP SYRINGE TO INFLATE WITH STATED ML OF STERILE WATER. OR FOR PRE-FILLED PRODUCTS, REMOVE CLIP AND SQUEEZE RESERVOIR TO INFLATE WITH STATED ML OF STERILE WATER. FOR UROLOGICAL USE ONLY. TO DEFLATE CATHETER BALLOON: GENTLY INSERT A LUER SLIP TIP SYRINGE IN THE CATHETER VALVE. NEVER USE MORE FORCE THAN IS REQUIRED TO MAKE THE SYRINGE ?STICK? IN THE VALVE. ALLOW THE PRESSURE WITHIN THE BALLOON TO FORCE THE PLUNGER BACK AND FILL THE SYRINGE WITH WATER. IF YOU NOTICE SLOW OR NO DEFLATION, RE-SEAT THE SYRINGE GENTLY. USE ONLY GENTLE ASPIRATION TO ENCOURAGE DEFLATION IF NEEDED. VIGOROUS ASPIRATION MAY COLLAPSE THE INFLATION LUMEN, PREVENTING BALLOON DEFLATION. IF NECESSARY, CONTACT ADEQUATELY TRAINED PROFESSIONAL FOR ASSISTANCE, AS DIRECTED BY HOSPITAL PROTOCOL. SHOULD BALLOON RUPTURE OCCUR, CARE SHOULD BE TAKEN TO ASSURE THAT ALL BALLOON FRAGMENTS HAVE BEEN REMOVED FROM THE PATIENT. A NEW CONNECTOR WITH A NEEDLE FREE SAMPLE PORT HAS BEEN ADDED TO THIS PRODUCT. INSTRUCTIONS FOR USE FOR THE NEEDLE-FREE SAMPLING KINK THE DRAINAGE TUBING AT A MINIMUM OF 5CM BELOW THE SAMPLING PORT. WIPE THE SURFACE OF THE PORT WITH AN ALCOHOL SWAB. USING AN ASEPTIC TECHNIQUE, POSITION THE SYRINGE (LUER SLIP TIP ONLY) IN THE CENTRE, PERPENDICULAR TO THE SURFACE OF THE PORT, AND THEN PRESS THE TIP OF THE SYRINGE INTO THE SAMPLING PORT. ASPIRATE THE DESIRED VOLUME AND THEN REMOVE THE SYRINGE. WIPE THE SURFACE OF THE PORT WITH AN ALCOHOL SWAB. UNKINK THE TUBING AND SEND THE CORRECTLY LABELED SPECIMEN TO THE LABORATORY." (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 KINKING IN THE TUBING OBSTRUCTED URINE. AS A RESULT, URINE DID NOT FLOW PROPERLY WHICH POTENTIALLY CAUSED BACKFLOW. THE HEALTHCARE PROFESSIONAL EXPLAINED THAT THE KINK MAY HAVE BEEN FROM BEING STORED TOO LONG. IT WAS ALSO REPORTED THAT THE RUBBER CONNECTION (PLIABLE SQUASH, KINK AND BEND) COULD RESTRICT FLOW AS WELL. THERE WAS NO REPORTED PATIENT INJURY AND NO URINE RETENTION.