BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1018233-2018-02509

    MDR report key: 7650200 · Received June 29, 2018

    Report

    Report Number
    1018233-2018-02509
    Event Type
    Malfunction
    Date Received
    June 29, 2018
    Date of Event
    June 8, 2018
    Report Date
    July 13, 2018
    PMA / PMN Number
    K760093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, CA
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "GENTLY INSERT A LUER SLIP TIP SYRINGE IN THE CATHETER VALVE. NEVER USE MORE FORCE THAN IS REQUIRED TO MAKE THE SYRINGE ¿STICK¿ IN THE VALVE. ALLOW THE PRESSURE WITHIN THE BALLOON TO FORCE THE PLUNGER BACK AND FI LL THE SYRINGE WITH WATER. IF YOU NOTICE SLOW OR NO DEFL ATION, RE-SEAT THE SYRINGE GENTLY. USE ONLY GENTLE ASPIRATION TO ENCOURAGE DEFL ATION IF NEEDED. VIGOROUS ASPIRATION MAY COLLAPSE THE INFL ATION LUMEN, PREVENTING BALLOON DEFL ATION. IF NECESSARY, CONTACT ADEQUATELY TRAINED PROFESSIONAL FOR ASSISTANCE, AS DIRECTED BY HOSPITAL PROTOCOL. SHOULD BALLOON RUPTURE OCCUR, CARE SHOULD BE TAKEN TO ASSURE THAT ALL BALLOON FRAGMENTS HAVE BEEN REMOVED FROM THE PATIENT. FEMALE USE ONLY SYRINGE OF STERILE WATER FOR BALLOON INFL ATION REFER TO DIRECT UNIT LABEL FOR PRODUCT CONTENT AND GENDER SPECIFI C USE WHERE APPLICABLE SINGLE USE ONLY. DO NOT RESTERILIZE 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. LOT NUMBER REORDER NUMBER USE BY DATE CAUTION, CONSULT ACCOMPANYING DOCUMENTS. CONSULT INSTRUCTIONS FOR USE UNITS DO NOT USE IF PACKAGE IS DAMAGED STERILIZED BY RADIATION OR STERILIZED BY ETHYLENE OXIDE REFER TO DIRECT UNIT LABEL FOR STERILIZATION METHOD UTILIZED BARD, BARDEX, BARDIA, BIOCATH AND LUBRICATH ARE TRADEMARKS AND/OR REGISTERED TRADEMARKS OF C. R. BARD, INC. WARNING: AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE LAWS AND REGULATIONS." THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED TWO OF THE CATHETERS LEAKED AND ALLEGEDLY CAUSED THE PATIENT STRESS WHEN THEY BYPASSED THE POINT OF INSERTION. ONE OF THE CATHETER'S BALLOON DID NOT DEFLATE. IT WAS LATER REPORTED ON (B)(6) 2018 FROM THE INTERNATIONAL BUSINESS CENTER (IBC), THE CATHETER WAS COMING OUT THROUGH THE STOMACH (SUPRAPUBICALLY), AND THE PATIENT ALLEGEDLY EXPERIENCED PAIN AND THEN SPOKE TO THE DIRECT NURSE WHO DECIDED TO LEAVE THE CATHETER IN PLACE FOR ANOTHER DAY, HOWEVER THE PAIN DID NOT EASE, SO THE CATHETER WAS CHANGED THE NEXT DAY AND WAS WORKING FINE. IT WAS LATER REPORTED ON (B)(6) 2018 FROM THE IBC, THE CATHETER WAS NOT INSERTED THROUGH THE URETHRA, IT WAS INSERTED SUPRAPUBICALLY. THERE WAS LEAKAGE FROM THE SUPRAPUBIC SITE, THE DIRECT NURSE TRIED TO DEFLATE THE BALLOON AFTER IT WAS REMOVED, HOWEVER IT DID NOT DEFLATE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED TWO OF THE CATHETERS LEAKED AND ALLEGEDLY CAUSED THE PATIENT STRESS WHEN THEY BYPASSED THE POINT OF INSERTION. ONE OF THE CATHETER'S BALLOON DID NOT DEFLATE. IT WAS LATER REPORTED ON (B)(6) 2018 FROM (B)(6), THE CATHETER WAS COMING OUT THROUGH THE STOMACH (SUPRAPUBICALLY), AND THE PATIENT ALLEGEDLY EXPERIENCED PAIN AND THEN SPOKE TO THE DIRECT NURSE WHO DECIDED TO LEAVE THE CATHETER IN PLACE FOR ANOTHER DAY, HOWEVER THE PAIN DID NOT EASE, SO THE CATHETER WAS CHANGED THE NEXT DAY AND WAS WORKING FINE. IT WAS LATER REPORTED ON (B)(6) 2018 FROM (B)(6), THE CATHETER WAS NOT INSERTED THROUGH THE URETHRA, IT WAS INSERTED SUPRAPUBICALLY. THERE WAS LEAKAGE FROM THE SUPRAPUBIC SITE, THE DIRECT NURSE TRIED TO DEFLATE THE BALLOON AFTER IT WAS REMOVED, HOWEVER IT DID NOT DEFLATE.

    Patients

    Seq Age Sex Outcome Treatment
    0