BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM
Report
- Report Number
- 1018233-2024-02904
- Event Type
- Malfunction
- Date Received
- May 23, 2024
- Date of Event
- May 1, 2024
- Report Date
- August 8, 2024
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- KNT
- UDI-DI
- 00801741045943
- PMA / PMN Number
- K133251
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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.
THE REPORTED EVENT WAS CONFIRMED CAUSE UNKNOWN. VISUAL EVALUATION OF THE RETURNED SIX- PHOTO SAMPLE NOTED ONE OPENED (WITHOUT ORIGINAL PACKAGING), USED DIGNISHIELD. VISUAL INSPECTION OF THE FIRST PHOTO SAMPLE NOTED THE GREEN INFLATION PORT BROKEN AND DISCONNECT FROM THE CATHETER AND ATTACHED TO THE SYRINGE FROM THE CATHETER. THE SECOND PHOTO NOTED WATER LEAKAGE FROM THE HOLE ON THE CATHETER FROM THE DISCONNECTED INFLATION PORT. THE THIRD AND FOURTH PHOTO NOTED THE GREEN INFLATION PORT NO LONGER INTACT AND CAUSING LEAKAGE OF STOOL. THE FIFTH PHOTO SHOWS THE DEFLATE BALLOON. THE SIXTH PHOTO SHOWS THE PORTS BROKEN FROM THE DIGNISHIELD. THIS DOES NOT MEET SPECIFICATION WHICH STATES DETACHED, INCORRECT ASSEMBLY AND DAMAGED CATHETER, ARMS AND CONNECTOR (FLUSH, INFLATION, & IRRIGATION) ARE NOT ALLOWED. THE EXACT ROOT CAUSE COULD NOT BE IDENTIFIED. ALTHOUGH A ROOT CAUSE COULD NOT BE DEFINITIVELY IDENTIFIED, BASED ON THE RISK DOCUMENTATION REVIEW, A POTENTIAL ROOT CAUSE FOR THIS TYPE OF FAILURE COULD BE COMPONENTS OUT OF SPECIFICATION. HOWEVER, THERE WAS INSUFFICIENT INFORMATION TO CONFIRM THIS POTENTIAL ROOT CAUSE. A DHR REVIEW IS NOT REQUIRED AS THE LOT NUMBER IS UNKNOWN. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: SMS002 BARD INSTRUCTIONS FOR USE: WARNING/ADVERTISEMENT/ADVERTENCIES 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- AIR 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. 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 PATIENTS ANUS. OBSERVE CHANGES IN THE LOCATION OF THE POSITION INDICATOR BAND AS A MEANS TO DETERMINE MOVEMENT OF THE RETENTION CUFF IN THE PATIENTS 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. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID AS REQUESTED. 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.
IT WAS REPORTED THAT THE GREEN INFLATION PORT POPPED OFF SYSTEM AND CAUSED LEAKAGE. THEY HAD TO REPLACE DEVICE. PER FOLLOW UP VIA EMAIL ON (B)(6) 2024, IT WAS REPORTED THAT ON (B)(6) 2024 AT FOUNDERS 9, THE PATIENT'S DIGNISHIELD WAS BROKEN OVERNIGHT, THE GREEN INFLATION PORT AND THE IRRIGATION PORTS HAD COME OUT. WHEN THEY WENT IN TO ASSESS THE PATIENT, THE RECTAL TUBE WAS LEAKING FROM THESE SITES. THEY ATTEMPTED TO REMOVE THE BROKEN TUBE, HOWEVER, WAS UNABLE TO DEFLATE THE BALLOON DUE TO THE INFLATION PORT BEING BROKEN. THEY TRIED STICKING THE SYRINGE INTO THE HOLE WHERE THE INFLATION PORT WOULD HAVE BEEN AND TRIED TO DRAIN IT THAT WAY, BUT IT DID NOT WORK. THEY ENDED UP CUTTING THE TUBE WHERE THE INFLATION LINE WAS IN THE HOPES THE BALLOON WOULD THEN DRAIN. THEY HAD TO SLOWLY REMOVE THE BALLOON AND TUBE FROM PATIENT. IT DID SLIGHTLY DEFLATE, HOWEVER THE BALLOON WAS SOMEWHAT STILL INFLATED ONCE COMPLETELY REMOVED FROM THE PATIENT. THEY WERE CONCERNED THAT HAD THE BALLOON BEEN FULLY INFLATED (OR OVER INFLATED) IT COULD HAVE CAUSED SERIOUS RECTAL TRAUMA TO THE PATIENT. THIS IS NOT THE FIRST TIME PORTS HAD BROKEN OFF OF DIGNISHIELDS. AND ON (B)(6) 2024 AT 7 CAMPUS (568153), UPON ASSESSMENT OF DIGNISHIELD FECAL MANAGEMENT SYSTEM, GREEN BALLOON PORT NO LONGER INTACT, CAUSING LEAKAGE OF STOOL. DEVICE WAS REMOVED FROM PATIENT AND NEW FECAL MANAGEMENT SYSTEM WAS PLACED. ON (B)(6) 2024 AT FOUNDERS 9 (568500), THEY WENT TO DISCONTINUE PATIENT'S FECAL MANAGEMENT SYSTEM. PORT TO INFLATE/DEFLATE BALLOON BROKEN OFF. NURSE ATTEMPTED TO DIFFERENT MEANS TO DEFLATE BALLOON IN PRIOR PORT SITE, BUT UNSUCCESSFUL. ON (B)(6) 2024 AT FOUNDERS 9 (568679), FECAL MANAGEMENT SYSTEM HAD BEEN HAVING MALFUNCTION WITH PORTS BREAKING OFF AND BALLOON SPONTANEOUSLY DEFLATING DESPITE ADEQUATE WATER INFLATION.
IT WAS REPORTED THAT THE GREEN INFLATION PORT POPPED OFF SYSTEM AND CAUSED LEAKAGE. THEY HAD TO REPLACE DEVICE. PER FOLLOW UP VIA EMAIL ON 08MAY2024, IT WAS REPORTED THAT ON (B)(6) 2024 AT FOUNDERS 9, THE PATIENTS DIGNISHIELD WAS BROKEN OVERNIGHT, THE GREEN INFLATION PORT AND THE IRRIGATION PORTS HAD COME OUT. WHEN THEY WENT IN TO ASSESS THE PATIENT, THE RECTAL TUBE WAS LEAKING FROM THESE SITES. THEY ATTEMPTED TO REMOVE THE BROKEN TUBE HOWEVER IT WAS UNABLE TO DEFLATE THE BALLOON DUE TO THE INFLATION PORT BEING BROKEN. THEY TRIED STICKING THE SYRINGE INTO THE HOLE WHERE THE INFLATION PORT WOULD HAVE BEEN AND TRIED TO DRAIN IT THAT WAY, BUT IT DID NOT WORK. THEY ENDED UP CUTTING THE TUBE WHERE THE INFLATION LINE WAS IN THE HOPES THE BALLOON WOULD THEN DRAIN. THEY HAD TO SLOWLY REMOVE THE BALLOON AND TUBE FROM PATIENT. IT DID SLIGHTLY DEFLATE; HOWEVER, THE BALLOON WAS SOMEWHAT STILL INFLATED ONCE COMPLETELY REMOVED FROM THE PATIENT. THEY WERE CONCERNED THAT HAD THE BALLOON BEEN FULLY INFLATED (OR OVER INFLATED) IT COULD HAVE CAUSED SERIOUS RECTAL TRAUMA TO THE PATIENT. THIS WAS NOT THE FIRST TIME PORTS HAD BROKEN OFF OF DIGNISHIELD. AND ON (B)(6) 2024 AT 7 CAMPUS ((B)(6)), UPON ASSESSMENT OF DIGNISHIELD FECAL MANAGEMENT SYSTEM, GREEN BALLOON PORT NO LONGER INTACT, CAUSING LEAKAGE OF STOOL. DEVICE WAS REMOVED FROM PATIENT AND NEW FECAL MANAGEMENT SYSTEM WAS PLACED. ON (B)(6) 2024 AT FOUNDERS 9 ((B)(6)), THEY WENT TO DISCONTINUE PATIENT'S FECAL MANAGEMENT SYSTEM. PORT TO INFLATE/DEFLATE BALLOON BROKEN OFF. NURSE ATTEMPTED TO DIFFERENT MEANS TO DEFLATE BALLOON IN PRIOR PORT SITE, BUT UNSUCCESSFUL. ON (B)(6) 2024 AT FOUNDERS 9 ((B)(6)), FECAL MANAGEMENT SYSTEM HAD BEEN HAVING MALFUNCTION WITH PORTS BREAKING OFF AND BALLOON SPONTANEOUSLY DEFLATING DESPITE ADEQUATE WATER INFLATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1788309 | BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM | DIGNISHIELD STOOL MANAGEMENT SYSTEM | KNT | C.R. BARD, INC. (COVINGTON) -1018233 | UNK | 00801741045943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |