BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX® I.C. COMPLETE CARE® URINE METER FOLEY TRAY

    MDR report key: 15370501 · Received September 7, 2022

    Report

    Report Number
    1018233-2022-06952
    Event Type
    Malfunction
    Date Received
    September 7, 2022
    Date of Event
    August 29, 2022
    Report Date
    November 2, 2022
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    MJC
    PMA / PMN Number
    K910318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE. NO SAMPLE WAS RETURNED FOR EVALUATION. IT IS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USED FOR UROLOGICAL CARE. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. THE POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE DUE TO DISTRIBUTION ERROR AS THE REPORTED EVENT IS NOT CAUSED BY BD. AS PER ATTACHED MEMO FROM MEDICON TEAM, IT IS CONFIRMED THAT THE NEAR-EXPIRED PRODUCTS WERE PROVIDED AS A REPLACEMENT FOR A PRODUCT THAT WAS OUT OF STOCK AND THE HOSPITAL WAS INFORMED ABOUT THE EXPIRATION DATE OF THE PRODUCTS. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "[WARNINGS] 1. METHOD FOR USE (1) DO NOT INFLATE THE BALLOON IN THE URETHRA. [THE URETHRA MAY BE INJURED.] (2) DO NOT PULL THE CATHETER HARD. [THE BLADDER/URETHRA MAY BE INJURED.] 2. APPLICABLE PATIENTS (1) PATIENTS WITH DELIRIUM WHO MIGHT PULL OUT CATHETER [WHEN PATIENT TUGS AT CATHETER UNCONSCIOUSLY, THE BLADDER AND URETHRA MAY BE DAMAGED.] [CONTRAINDICATIONS] 1. METHOD FOR USE: (1) DO NOT REUSE. (2) DO NOT RESTERILIZE. (3) THIS DEVICE CONTAINS 10% POVIDONE-IODINE. FOR PATIENTS WITH PAST HISTORY OF ALLERGIC HYPERSENSITIVITY TO POVIDONE-IODINE OR IODINE, CONSIDER USING ALTERNATIVE DISINFECTANTS. (4) BE CAREFUL THAT THE CATHETER IS NOT EXPOSED TO OINTMENTS, CONTRAST MEDIUM OR OIL-BASED LUBRICANTS (INCLUDING VEGETABLE OILS SUCH AS OLIVE OIL, MINERAL OILS SUCH AS WHITE PETROLATUM AND ANIMAL OILS). [THEY MAY DAMAGE THE DEVICE AND MAY BURST BALLOON.] (5) DO NOT HOLD THE DEVICE WITH FORCEPS, ETC. AVOID CONTACT WITH ANY BLADES OR SHARP-EDGED INSTRUMENTS. [CATHETER DAMAGE MAY CAUSE BALLOON RUPTURE AND ACCIDENTAL BALLOON REMOVAL OR FAILURE TO DEFLATE OR REMOVE THE BALLOON.] 2. APPLICABLE PATIENTS (1) DO NOT USE IN PATIENTS WHO ARE OR HAVE BEEN ALLERGIC TO NATURAL RUBBER LATEX [INTENDED USE & EFFECT- EFFICACY] THE DEVICE COMBINES AN INDWELLING BLADDER CATHETER AND A URINARY DRAINAGE BAG THAT ARE USED FOR URINARY DRAINAGE AND BLADDER IRRIGATION. [PRECAUTIONS] 1. PRECAUTIONS FOR USE (EXERCISE CAUTION WHEN USING THE DEVICE IN THE FOLLOWING PATIENTS) (1) EXERCISE CAUTION WHEN USING THE DEVICE IN PATIENTS WITH HIGH URINARY CALCIUM LEVELS AS ENCRUSTATION ON THE BALLOON SURFACE, CATHETER OCCLUSION OR DAMAGE MAY OCCUR. 2. IMPORTANT PRECAUTIONS (1) WHEN CATHETER IS INADVERTENTLY REMOVED, INSPECT THE BALLOON AND SHAFT OF CATHETER FOR RUPTURE, DEFECT, ETC. BEFORE INSERTING A NEW CATHETER. (2) WHEN ANY PART OF THE BALLOON AND/OR THE CATHETER IS MISSING, CONSIDER REMOVING THEM USING A CYSTOSCOPE. (3) WHEN IT IS DIFFICULT TO REMOVE CATHETER BY DEFLATING THE BALLOON, TAKE APPROPRIATE MEASURES ACCORDING TO THE SECTION ¿TROUBLESHOOTING¿. 3. MALFUNCTION AND ADVERSE EVENTS 1) MALFUNCTION - CATHETER KINKING, DAMAGE, RUPTURE - DIFFICULTY OR FAILURE TO REMOVE THE DEVICE - OCCLUSION OF CATHETER INNER LUMENS - ENCRUSTATION - ACCIDENTAL REMOVAL OF THE DEVICE DUE TO LEAKAGE OF STERILE WATER OR BALLOON RUPTURE - DEVICE DAMAGE DUE TO INAPPROPRIATE USE 2) ADVERSE EVENTS - URINARY-TRACT INFECTION - HEMORRHAGE, HEMATURIA - ALLERGY REACTION TO THE DEVICE - CALCULUS FORMATION - EDEMA - PAIN - DISCOMFORT - INJURY OF BLADDER OR URETHRAL - URETHRITIS, URINARY INCONTINENCE - RETAINED BALLOON FRAGMENTS [STORAGE METHOD AND EXPIRATION DATE] 1. STORAGE STORE IN A DRY, COOL PLACE AWAY FROM HEAT, MOISTURE, AND DIRECT SUNLIGHT. 2. EXPIRATION DATE INDICATED ON THE DIRECT PACKAGE AND THE OUTER BOX." H11: SECTION A THROUGH F - 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. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED

    Description of Event or Problem · 0

    IT WAS REPORTED THAT EXPIRED PRODUCTS HAD BEEN USED. IT WAS MENTIONED THAT NEAR-EXPIRED PRODUCTS WERE PROVIDED AS A REPLACEMENT FOR A PRODUCT THAT WAS OUT OF STOCK. THE HOSPITAL WAS INFORMED ABOUT THE EXPIRATION DATE OF THE PRODUCTS. HOWEVER, IT WAS STATED THAT 4 EXPIRED PRODUCTS WERE USED AT THE HOSPITAL. THE HOSPITAL RECEIVED ANY COMPLAINTS FROM MEDICON.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT EXPIRED PRODUCTS HAD BEEN USED. IT WAS MENTIONED THAT NEAR-EXPIRED PRODUCTS WERE PROVIDED AS A REPLACEMENT FOR A PRODUCT THAT WAS OUT OF STOCK. THE HOSPITAL WAS INFORMED ABOUT THE EXPIRATION DATE OF THE PRODUCTS. HOWEVER, IT WAS STATED THAT 4 EXPIRED PRODUCTS WERE USED AT THE HOSPITAL. THE HOSPITAL RECEIVED ANY COMPLAINTS FROM MEDICON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2617639 BARDEX® I.C. COMPLETE CARE® URINE METER FOLEY TRAY FOLEY TRAY MJC C.R. BARD, INC. (COVINGTON) -1018233 MYDU6646

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other