BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM
Report
- Report Number
- 1018233-2023-09045
- Event Type
- Malfunction
- Date Received
- December 19, 2023
- Date of Event
- December 1, 2023
- Report Date
- January 3, 2024
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- KNT
- PMA / PMN Number
- K133251
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE DUE TO "PARAMETERS OF UV GENERATOR OUT OF SPECIFICATION". THE DHR REVIEW COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿SMS002 BARD® INSTRUCTIONS FOR USE WARNING/AVERTISSEMEN/ADVERTENCIA THERE IS A POTENTIAL RISK OF MISCONNECTIONS WITH CONNECTORS FROM OTHER HEALTHCARE APPLICATIONS, SUCH AS INTRAVENOUS EQUIPMENT, BREATHING AND DRIVING GAS SYSTEMS, URETHRAL/URINARY, LIMB CUFF INFLATION, NEURAXIAL DEVICES AND OTHER ENTERAL AND GASTRIC APPLICATIONS.A PISTON VALVE CONNECTOR LOCATED ON THE END OF THE DRAINAGE TUBE OF THE CATHETER ATTACHES TO THE COLLECTION BAG HUB SOCKET. WHEN THE COLLECTION BAG IS DISENGAGED FROM THE CATHETER, THE CATHETER AND BAG AUTOMATICALLY CLOSE TO PREVENT SPILLAGE. A BAG CAP IS PROVIDED TO SECURE THE CONTENTS OF THE COLLECTION BAG WHEN THE CATHETER IS REMOVED. THE 50 ML SYRINGE AND LUBRICATING JELLY SYRINGE ARE USED IN THE PREPARATION AND USE OF THE CATHETER. THE MEDI-AIRE® BIOLOGICAL ODOR ELIMINATOR MAY BE USED AS AN AIR FRESHENER IN THE ROOM. DO NOT SPRAY ON PATIENT OR DEVICE. THE TUBE CLAMP IS USED TO RETAIN MEDICATION DURING ADMINISTRATION OF MEDICATION. DIRECTIONS FOR USE: PUMP SPRAYER ONCE OR TWICE. DIRECT SPRAY AWAY FROM PATIENT. CONTAINS: WATER, SD ALCOHOL 40, TRIETHYLENE GLYCOL, BENZETHONIUM CHLORIDE, D&C COLOR, TETRASODIUM EDTA. CAUTION: MAY BE HARMFUL IF SWALLOWED. AVOID EYE CONTACT. KEEP OUT OF REACH OF CHILDREN. GENERAL GUIDELINES: THE DEVICE MAY BE REPLACED AS NEEDED, TO PERFORM PATIENT ASSESSMENT. FOR MEDICAL OR TECHNICAL QUESTIONS, PLEASE CONTACT MEDICAL SERVICES AND SUPPORT 800-227-3357. IF FURTHER INFORMATION OR GUIDELINES ARE NEEDED, PLEASE CONTACT BARD MEDICAL, AT THE ADDRESS BELOW: C. R. BARD, INC. COVINGTON, GA 30014 USA 1-800-526-4455 ASSEMBLED IN MEXICO WWW.BARDMEDICAL.COM BARD, DIGNISHIELD, MEDI-AIRE AND PERMALENE ARE TRADEMARKS AND/OR REGISTERED TRADEMARKS OF C. R. BARD, INC. ©2020 C. R. BARD, INC. ALL RIGHTS RESERVED. 11. SYSTEM CARE, MAINTENANCE, AND MONITORING OF DEVICE A. TAKE NOTE OF THE BLACK POSITION INDICATOR LINE THAT IS PRINTED IN THE PROXIMAL SEGMENT OF THE TSZ. OBSERVE ITS RELATIVE POSITION TO THE PATIENT¿S ANUS. OBSERVE CHANGES IN THE LOCATION OF THE POSITION INDICATOR BAND AS A MEANS TO DETERMINE MOVEMENT OF THE RETENTION CUFF IN THE PATIENT¿S RECTUM. THIS MAY INDICATE THE NEED FOR THE CUFF OR DRAINAGE TUBE TO BE REPOSITIONED. B. CHANGE THE COLLECTION BAG AS NEEDED. C. SECURE THE BAG CAP ONTO EACH USED COLLECTION BAG AND DISCARD ACCORDING TO INSTITUTIONAL PROTOCOL FOR DISPOSAL OF MEDICAL WASTE. D. TO ENSURE UNOBSTRUCTED FLOW OF FECAL MATTER FROM THE DRAINAGE TUBE TO THE COLLECTION BAG, FREQUENTLY VERIFY THAT THE CATHETER AND COLLECTION BAG ARE POSITIONED SO THAT THE CATHETER IS NOT TWISTED, KINKED, OR EXTERNALLY COMPRESSED. E. FREQUENTLY VERIFY THAT WASTE IS NOT ACCUMULATING IN THE CATHETER DRAINAGE TUBE. F. VERIFY PATIENT IS NOT LYING ON DRAINAGE TUBE OR PORTS IN SUCH A MANNER AS TO POTENTIALLY CAUSE DISCOMFORT OR LOCALIZED PROLONGED PRESSURE. G. CHECK THE RETENTION CUFF VOLUME REGULARLY TO ENSURE PROPER INFLATION.¿ H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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 BD. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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 BD. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.
IT WAS REPORTED THAT 25 DAYS AFTER IMPLANTATION, FAECAL LEAKAGE OCCURRED FROM THE CONNECTION BETWEEN THE FLUSH PORT AND THE TUBE. THE FLUSH PORT WAS NEVER USED.
IT WAS REPORTED THAT 25 DAYS AFTER IMPLANTATION, FAECAL LEAKAGE OCCURRED FROM THE CONNECTION BETWEEN THE FLUSH PORT AND THE TUBE. THE FLUSH PORT WAS NEVER USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1350205 | BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM | DIGNISHIELD STOOL MANAGEMENT SYSTEM | KNT | C.R. BARD, INC. (COVINGTON) -1018233 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |