BARD® URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER
Report
- Report Number
- 1018233-2025-06966
- Event Type
- Malfunction
- Date Received
- August 22, 2025
- Date of Event
- July 22, 2025
- Report Date
- August 28, 2025
- Manufacturer
- C.R. BARD INC. (COVINGTON) -1018233
- Product Code
- KNX
- UDI-DI
- 00801741029509
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. NO ACTIONS CAN BE TAKEN AT THIS TIME SINCE A ROOT CAUSE WAS NOT IDENTIFIED. A DHR COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: INDICATIONS FOR USE: THE URINE DRAINAGE BAGS, AND URINE METERS ARE INDICATED FOR URINE COLLECTION FOR PATIENTS REQUIRING URINARY CATHETERIZATION. INTENDED USE: FOR UROLOGICAL USE ONLY. CONTRAINDICATIONS: NO KNOWN CONTRAINDICATIONS. WARNINGS: AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTABLE MEDICAL PRACTICES AND APPLICABLE LOCAL, STATE AND FEDERAL LAWS AND REGULATIONS. THIS IS A SINGLE USE DEVICE. DO NOT RESTERILIZE ANY PORTION OF THIS DEVICE. REUSE AND/OR REPACKAGING MAY CREATE A RISK OF PATIENT OR USER INFECTION, COMPROMISE THE STRUCTURAL INTEGRITY AND/OR ESSENTIAL MATERIAL AND DESIGN CHARACTERISTICS OF THE DEVICE, WHICH MAY LEAD TO DEVICE FAILURE, AND/OR LEAD TO INJURY, ILLNESS OR DEATH OF THE PATIENT. USERS AND/OR PATIENTS WITHIN THE EUROPEAN UNION, SHOULD REPORT ANY SERIOUS INCIDENT THAT HAS OCCURRED IN RELATION TO THE DEVICE TO THE MANUFACTURER AND THE COMPETENT AUTHORITY OF THE MEMBER STATE IN WHICH THE USER AND/OR PATIENT IS ESTABLISHED. USERS OUTSIDE OF THE EUROPEAN UNION SHOULD REPORT ANY SERIOUS INCIDENT THAT HAS OCCURRED IN RELATION TO THE DEVICE TO THE MANUFACTURER AND THE REGULATORY AUTHORITY OF THE COUNTRY IN WHICH THE USER AND/OR PATIENT IS ESTABLISHED. CAUTIONS: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A LICENSED HEALTHCARE PRACTITIONER. CONTAINS OR PRESENCE OF PHTHALATES: DI(2-ETHYLHEXYL) PHTHALATE (DEHP) IS A PLASTICIZER USED IN SOME POLYVINYL CHLORIDE MEDICAL DEVICES. DEHP HAS BEEN SHOWN TO PRODUCE A RANGE OF ADVERSE EFFECTS IN EXPERIMENTAL ANIMALS, NOTABLY LIVER TOXICITY, AND TESTICULAR ATROPHY. ALTHOUGH THE TOXIC AND CARCINOGENIC EFFECTS OF DEHP HAVE BEEN WELL ESTABLISHED IN EXPERIMENTAL ANIMALS, THE ABILITY OF THIS COMPOUND TO PRODUCE ADVERSE EFFECTS IN HUMANS IS CONTROVERSIAL. THERE IS NO EVIDENCE THAT NEONATES, INFANTS, PREGNANT AND BREAST-FEEDING WOMEN EXPOSED TO DEHP EXPERIENCE ANY RELATED ADVERSE EFFECTS. HOWEVER, A LACK OF EVIDENCE OF CAUSATION BETWEEN DEHP-PVC AND ANY DISEASE OR ADVERSE EFFECT DOES NOT MEAN THAT THERE IS NO RISK. PRECAUTION: DO NOT USE DEVICE IF PACKAGE IS OPENED OR DAMAGED. INSTRUCTIONS FOR USE: VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. IF PACKAGE IS OPENED OR IF ANY IMPERFECTION OR SURFACE DETERIORATION IS OBSERVED, DO NOT USE. 1. REMOVE PROTECTIVE CAP FROM DRAINAGE TUBE CATHETER ADAPTER AND CONNECT DRAINAGE TUBE TO CATHETER. 2. POSITION HANGER ON BEDSIDE RAIL, USING STRING OR HOOK. 3. USE SHEETING CLIP TO SECURE DRAINAGE TUBE TO SHEET. A. HANG DRAINAGE TUBE IN A STRAIGHT FASHION FROM BEDSIDE TO DRAINAGE BAG. ENSURE THAT THE DRAINAGE BAG IS PLACED NEAR THE FOOT OF THE BED. 4. IF USING A URINE METER, IT MAY BE EMPTIED IN TWO WAYS: A. TO EMPTY INTO THE BAG, GRASP THE BOTTOM OF THE METER AND LIFT UP. TO ENSURE THAT THE METER EMPTIES COMPLETELY, LIFTING AGAIN IS RECOMMENDED. B. TO EMPTY URINE METER INTO RECEPTACLE, TWIST GREEN PORTION OF DRAIN VALVE TO THE LEFT; TO CLOSE, TWIST GREEN POSITION OF THE DRAIN VALVE TO THE RIGHT. 5. TO EMPTY BAG: A. REMOVE OUTLET TUBE FROM HOUSING; GENTLY SQUEEZE CONNECTOR ARMS AND PULL TUBE FROM HOUSING. B. RELEASE CLAMP AND EMPTY BAG. C. AFTER EMPTYING, RE CLAMP OUTLET TUBE AND SLIDE CONNECTOR INTO HOUSING UNTIL CONNECTOR ARMS ENGAGE. D. IF SPECIMEN IS REQUIRED, SEE INSTRUCTIONS FOR USING URINE SAMPLING PORT. 6. PERIODIC OBSERVATIONS OF THIS SYSTEM SHOULD BE MADE TO ENSURE THAT URINE IS FLOWING FREELY. IF A STANDING COLUMN OF URINE IS OBSERVED, CHECK FOR CORRECT POSITIONING OF BAG AND THEN FOR A PHYSICAL OBSTRUCTION. IF CORRECT POSITIONING OR REMOVAL OF PHYSICAL OBSTRUCTION DOES NOT ALLOW FREE FLOW, THE BAG MAY HAVE TO BE CHANGED. A. IF BAG IS NOT POSITIONED CORRECTLY, URINE MAY BYPASS THE METER AND GO DIRECTLY TO THE BAG. REPOSITION BAG, AS NECESSARY. DIRECTIONS FOR USING BARD SAMPLING PORT: BARD SAMPLING PORT ACCEPTS A LUER-LOCK OR SLIP TIP SYRINGE. 1. KINK DRAINAGE TUBING A MINIMUM OF 3 INCHES BELOW THE SAMPLING PORT UNTIL URINE IS VISIBLE UNDER THE ACCESS SITE. 2. SWAB SURFACE OF SITE WITH ANTISEPTIC WIPE. 3. USING ASEPTIC TECHNIQUE, POSITION THE SYRINGE IN THE CENTER OF THE SAMPLING PORT. THE SYRINGE SHOULD BE HELD PERPENDICULAR TO THE SURFACE OF THE SAMPLING PORT (AT APPROXIMATELY 80 TO 100 DEGREE ANGLE). PRESS THE SYRINGE FIRMLY AND TWIST GENTLY TO LOCK THE SYRINGE ONTO THE SAMPLING PORT. A. IMPROPER PENETRATION TECHNIQUE COULD CAUSE FORMATION OF A DROP OF URINE ON THE SURFACE OF THE SAMPLING PORT. PERIODIC OBSERVATION OF THE SAMPLING PORT IS RECOMMENDED. 4. ASPIRATE DESIRED VOLUME OF URINE. 5. UNKINK TUBING AND SEND SPECIMEN TO LABORATORY. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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 THEY HAD ONE ISSUE ON (B)(6) 2025 WITH THE BAG NOT DRAINING, PRODUCT CONCERN FORM WAS SUBMITTED, AND THE SECOND INCIDENT OF THE BAG NOT DRAINING OCCURRED OVERNIGHT, PRODUCT CONCERN FORM WAS SUBMITTED THAT MORNING. THEY HAD AN ADDITIONAL ISSUE OF A FOLEY BAG LEAKING THEY DID NOT THINK A PRODUCT CONCERN FORM WAS SUBMITTED. THEY TOLD BY LABOR AND DELIVERY THAT WITHIN THE LAST 2 DAYS THEY ALSO ENCOUNTERED A FOLEY BAG THAT WAS NOT DRAINING, THEY DID NOT KNOW IF A CONCERN FORM WAS SUBMITTED. IN LOOKED AT THE LIST OF 17 CONCERNS THERE WERE MANY SIMILAR CONCERNS WITH THE FOLEY BAG OR THE BALLOON LEAKING. THAT ALSO APPEARED THAT THE MAJORITY OF OUR CONCERNS ARE FROM 2 DIFFERENT GROUPS OF FOLEYS IN MULTIPLE SIZES WITHIN THE GROUP. GROUP 1: A947314 FOR SIZE FOR FOLEY BAG (PCN#154002) AND FOR CATHETER (PCN#175814). GROUP 2: A3195AE¿ FOR SIZE FOR DRAIN BAG (PCN#Z10) AND FOR CATHETER (PCN#Z01). LABOR AND DELIVERY PULLED ABOUT 25 OF THE FOLEY TRAYS WITH LOT #NGKP4405 AND THEY HAD PULLED 3 FROM THE MBU STOCK. HRPS AND PRODUCT CONCERN FORM (4616-PC) WERE COMPLETED. THE TWO USED, DEFECTIVE FOLEYS WERE SAVED AND AVAILABLE TO BE PICKED UP. THEY WERE ALL IN KALEYA OFFICE, THEY CAN HELP SOMEONE TO RETRIEVE THEM IF NEEDED.
IT WAS REPORTED THAT THEY HAD ONE ISSUE ON (B)(6) 2025 WITH THE BAG NOT DRAINING, PRODUCT CONCERN FORM WAS SUBMITTED, AND THE SECOND INCIDENT OF THE BAG NOT DRAINING OCCURRED OVERNIGHT, PRODUCT CONCERN FORM WAS SUBMITTED THAT MORNING. THEY HAD AN ADDITIONAL ISSUE OF A FOLEY BAG LEAKING THEY DID NOT THINK A PRODUCT CONCERN FORM WAS SUBMITTED. THEY TOLD BY LABOR AND DELIVERY THAT WITHIN THE LAST 2 DAYS THEY ALSO ENCOUNTERED A FOLEY BAG THAT WAS NOT DRAINING, THEY DID NOT KNOW IF A CONCERN FORM WAS SUBMITTED. IN LOOKED AT THE LIST OF 17 CONCERNS THERE WERE MANY SIMILAR CONCERNS WITH THE FOLEY BAG OR THE BALLOON LEAKING. THAT ALSO APPEARED THAT THE MAJORITY OF OUR CONCERNS ARE FROM 2 DIFFERENT GROUPS OF FOLEYS IN MULTIPLE SIZES WITHIN THE GROUP. GROUP 1: (B)(6) FOR SIZE FOR FOLEY BAG ((B)(6)) AND FOR CATHETER ((B)(6)). GROUP 2: (B)(6)¿ FOR SIZE FOR DRAIN BAG (Z10) AND FOR CATHETER ((B)(6)) LABOR AND DELIVERY PULLED ABOUT 25 OF THE FOLEY TRAYS WITH LOT #NGKP4405 AND THEY HAD PULLED 3 FROM THE MBU STOCK. HRPS AND PRODUCT CONCERN FORM (4616-PC) WERE COMPLETED. THE TWO USED, DEFECTIVE FOLEYS WERE SAVED AND AVAILABLE TO BE PICKED UP. THEY WERE ALL IN (B)(6) OFFICE, THEY CAN HELP SOMEONE TO RETRIEVE THEM IF NEEDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2618718 | BARD® URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER | DRAIN BAG | KNX | C.R. BARD INC. (COVINGTON) -1018233 | UNK | 00801741029509 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |