BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM
Report
- Report Number
- 1018233-2024-02804
- Event Type
- Malfunction
- Date Received
- May 17, 2024
- Date of Event
- April 26, 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 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. 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 "INAPPROPRIATE ADHESIVE (POOR ADHESION BETWEEN MATERIALS)". HOWEVER, THERE WAS INSUFFICIENT INFORMATION TO CONFIRM THIS POTENTIAL ROOT CAUSE. THE REPORTED EVENT IS ADDRESSED AND THE RESIDUAL RISK FOR THIS EVENT IS LOW. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "1. PREPARATION OF SMS PRIOR TO INSERTION A. VERIFY THE RETENTION CUFF HAS BEEN COMPLETELY DEFLATED. THIS CAN BE DONE BY SQUEEZING THE CUFF TO ENSURE THERE IS NO RESIDUAL AIR INSIDE THE DEVICE. 1) IF AIR REMAINS WITHIN THE CUFF, ATTACH THE 50 ML SYRINGE TO THE GREEN INFLATION PORT AND WITHDRAW ALL REMAINING AIR FROM THE CUFF. B. AFTER THE CUFF HAS BEEN FULLY DEFLATED, FILL THE SYRINGE WITH 45ML OF WATER AND SET ASIDE. C. USING A PERMANENT MARKER, RECORD THE CATHETER INSERTION DATE ON THE LABEL LOCATED ON THE PISTON VALVE CONNECTOR." " 4. INSERTION OF DEVICE A. UNFOLD THE LENGTH OF THE CATHETER TO LAY FLAT ON THE BED, EXTENDING THE COLLECTION BAG TOWARDS THE FOOT OF THE BED. B. ATTACH THE 50 ML SYRINGE FILLED WITH 45 ML OF WATER TO THE INFLATION PORT, BUT DO NOT INFLATE. C. INSERT THE INFLATION CUFF USING A FOUR-STEP PROCESS: 1) AS PREVIOUSLY STATED IN STEP 1, ¿PREPARATION OF SMS PRIOR TO INSERTION¿, ENSURE THE RETENTION CUFF IS COMPLETELY DEFLATED. 2) HOLDING THE LEFT POINT OF THE CUFF BETWEEN THE THUMB AND INDEX FINGER, FOLD THE TOP RIGHT POINT OF THE CUFF DOWN AND TO THE LEFT IN A 45 DEGREE ANGLE , IN ORDER TO CREATE A CONICAL SHAPE WITH A LEADING EDGE FOR EASY INSERTION. 3) GENEROUSLY COAT THE PATIENT¿S ANUS WITH LUBRICATING JELLY. 4) GENTLY INSERT THE CUFF END THROUGH THE ANAL SPHINCTER UNTIL THE CUFF IS BEYOND THE EXTERNAL ORIFICE AND WELL INSIDE THE RECTAL VAULT. D. INFLATE THE CUFF WITH 45ML OF WATER BY SLOWLY DEPRESSING THE SYRINGE PLUNGER. THE GREEN INFLATION PORT HAS AN EXTERNAL PILOT BALLOON USED AS A GUIDE TO DETERMINE PROPER INFLATION; AS THE CUFF INFLATES, THE PILOT BALLOON ALSO INFLATES. THE PILOT BALLOON SHOULD BE USED AS A REFERENCE TO DETERMINE PROPER CUFF INFLATION. IF THE PILOT BALLOON INDICATES OVER- OR UNDER-INFLATION, USE THE SYRINGE TO WITHDRAW THE FLUID FROM THE CUFF, REPOSITION THE CUFF IN THE RECTAL VAULT AND REINFLATE. ENSURE THE INFLATION PORT REMAINS PARALLEL TO THE CATHETER IN ORDER TO PREVENT KINKING OF THE INFLATION LUMEN AND BLOCKAGE OF INJECTED FLUID. INFLATE THE CUFF WITH 45 ML OF WATER BY SLOWLY DEPRESSING THE SYRINGE PLUNGER. THE INFLATION PORT HAS AN EXTERNAL PILOT BALLOON AS A GUIDE TO DETERMINE PROPER INFLATION; AS THE CUFF INFLATES, THE PILOT BALLOON ALSO INFLATES. THE PILOT BALLOON SHOULD BE USED AS A REFERENCE TO DETERMINE PROPER CUFF INFLATION E. REMOVE THE SYRINGE FROM THE GREEN INFLATION PORT AND GENTLY PULL ON THE DRAINAGE CATHETER TO CHECK THAT THE CUFF IS SECURELY IN THE RECTUM AND THAT IT IS POSITIONED AGAINST THE RECTAL FLOOR. F. POSITION THE LENGTH OF THE FLEXIBLE DRAINAGE TUBE ALONG THE PATIENT¿S LEG, AVOIDING KINKS, OBSTRUCTION AND TENSION. ¿ 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. G. HANG THE BAG USING THE BUILT-IN HANGER AT A CONVENIENT LOCATION ON THE BEDSIDE." 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.
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.
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 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 ((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 OR 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.
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 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 OR 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2520927 | BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM | STOOL MANAGEMENT SYSTEM | KNT | C.R. BARD, INC. (COVINGTON) -1018233 | UNK | 00801741045943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |