| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | BARD DISPOZ-A-BAG LEG BAG | LEG BAG | PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 | FAQ | UNK | UNK | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-04-12 | 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 URINE LEAKED INTO THE INLET TUBE. SUBSEQUENTLY, THE URINE WOULD NOT FLOW INTO THE BAG.
Patient 1
RECEIVED 1 USED DIZPOZ-A-BAG ONLY. THE REPORTED EVENT WAS UNCONFIRMED, AS THE PROBLEM COULD NOT BE REPRODUCED. VISUAL INSPECTION NOTED NO OBVIOUS DEFECTS ON THE SAMPLE RECEIVED. THE SAMPLE WAS INSPECTED AND DID NOT SEE ANY FOLDS IN THE FLUTTER VALVE THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE SAMPLE WAS RECEIVED WITH EXTENSION TUBING. PER FUNCTIONAL EVALUATION, THE SAMPLE RECEIVED WAS FUNCTIONALLY TESTED, THE EXTENSION TUBE IS PART OF THE SAMPLE RECEIVED WAS CONNECTED TO A NEW 16 FR. CATHETER (IS NOT PART OF THE SAMPLE RECEIVED) AFTER THE SAMPLE WAS TESTED PASSING WATER THROUGH OF NEW 16 FR. CATHETER, AND NOTED THE LIQUID FLOW TOWARD THE INTERIOR OF THE BAGS UNTIL IS FILLED TO ITS MAXIMUM CAPACITY. DURING THIS TEST, DID NOT NOTE THAT THE FLOW STOPPED. THE FLOW WAS CONTINUOUS. AT LAST, THE LIQUID OF THE LEG BAGS WAS DRAINED TO THE EXTERIOR OF THE BAGS AND DID NOT NOTE ANY DIFFICULTY OR PROBLEM TO DRAIN. ADDITIONALLY THE VINYL?S WERE CUT TO VERIFY THE EMBOSSED OF THE BAGS TO BE CORRECT ON THE SAMPLE RECEIVED AND NO PROBLEM NOTED ON THE EMBOSSED. DURING THE TEST OF THE SAMPLE RECEIVED IN THE ASSEMBLY EXTENSION TUBING TO BAG NOT WAS OBSERVED PROBLEM OF THE LEAK IN THE ASSEMBLY. AFTER THAT, THE BAG WAS CUT CHECKED THE EMBOSSED ON THE FLUTTER VALVE ON THE SAMPLE RECEIVED. REVIEWED THE INLET TUBE OF THE BAG WHERE THE FLUTTER VALVE IS SEALED FOR ANY TYPE OF OBSTRUCTION AND NO PROBLEM WAS FOUND. REVIEWED THAT THE FLUTTER VALVE WAS NOT BEND OR HAD ANY TYPE OF OBSTRUCTION AND NO PROBLEM WAS FOUND. REVIEWED THE EMBOSSED OF THE FLUTTER VALVE, WHICH IS ON THE EXTERNAL PART; THEREFORE, THE ASSEMBLY IS CORRECT. REVIEWED THE EMBOSSED OF THE CLEAR VINYL OF THE LEG BAG, WHICH IS ON THE INTERNAL PART; THEREFORE, THE ASSEMBLY IS CORRECT. REVIEWED THE PERIPHERAL SEAL, ROTARY SEAL OF THE BAGS AND NO PROBLEM WAS FOUND. NO PROBLEM COULD BE NOTICED ON THE FLUTTER VALVE ON THE SAMPLE RECEIVED 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: "- POSITION BAG ON LEG WITH FLUTTER VALVE AT TOP. - ATTACH CATHETER OR EXTENSION TUBING TO TOP INLET. WHEN WEARING BAG BELOW KNEE, ATTACH BARD? EXTENSION TUBING (CATALOG NO. 150615 OR 4A4194). WHEN USING EXTENSION TUBING, MAKE SURE TO CONNECT TUBE AT LEAST TO THE 3RD TAPER OF THE CONNECTOR. -TO EMPTY DISPOZ-A-BAG?, PUSH GREEN LEVER ON FLIP-FLO? VALVE OUT AND DOWN." (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 URINE LEAKED INTO THE INLET TUBE. SUBSEQUENTLY, THE URINE WOULD NOT FLOW INTO THE BAG.