BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD FOLEY CATHETER

    MDR report key: 189048 · Received September 23, 1998

    Report

    Report Number
    MW4002336
    Event Type
    Malfunction
    Date Received
    September 23, 1998
    Date of Event
    July 1, 1998
    Report Date
    September 8, 1998
    Manufacturer
    C.R. BARD, INC.
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RPTR WRITES, "PLEASE NOTE THIS IS ONLY AN "FYI" LETTER IN CASE YOU HAVE BEEN NOTIFIED OF ANY OTHER SITUATIONS WHICH ARE SIMILAR TO THE FOLLOWING. WE HAVE HAD NO SERIOUS EVENTS OCCUR AS A RESULT, BUT FEEL THERE IS POTENTIAL. OVER THE PAST FEW MONTHS WE HAVE HAD PROBLEMS WITH DEFECTS IN OUR BARD FOLEY CATHETERS USED AT" THE FACILITY, "AND ONE OF OUR AFFILIATE FACILITIES". OUR FIRST INCIDENT OCCURRED ON A MALE PT IN THE FIRST PART OF JULY, 1998. THE BARD FOLEY CATHETER'S BALLOON WOULD NOT DEFLATE IN ORDER TO DISCONTINUE THE FOLEY. THIS PARTICULAR PT HAD TO BE TAKEN TO OUR LARGER FACILITY IN ORDER FOR ONE OF OUR UROLOGISTS TO REMOVE THE CATHETER. OUR SALES REP FROM BARD WAS NOTIFIED OF THE DEFECT AND STATED HE WOULD GET IN CONTACT WITH THEIR QUALITY CONTROL REP. FORTUNATELY, WE HAVE HAD NO SERIOUS OCCURRENCES DUE TO THESE DEFECTS AT THIS POINT; HOWEVER, AS I STATED BEFORE, I DO FEEL THERE IS A POTENTIAL FOR A SERIOUS ADVERSE EVENT TO OCCUR. WE ARE STAYING ON TOP OF THIS SITUATION AND WILL BE IN CONTINUOUS CONTACT WITH BARD UNTIL WE GET THE PROBLEM RESOLVED OR DECIDE TO CHANGE VENDORS.

    Description of Event or Problem · 2

    RPTR WRITES, "PLEASE NOTE THIS IS ONLY AN "FYI" LETTER IN CASE YOU HAVE BEEN NOTIFIED OF ANY OTHER SITUATIONS WHICH ARE SIMILAR TO THE FOLLOWING. WE HAVE HAD NO SERIOUS EVENTS OCCUR AS A RESULT, BUT FEEL THERE IS POTENTIAL. OVER THE PAST FEW MONTHS WE HAVE HAD PROBLEMS WITH DEFECTS IN OUR BARD FOLEY CATHETERS USED AT" THE FACILITY, "AND ONE OF OUR AFFILIATE FACILITIES". THE SECOND INCIDENT ALSO OCCURRED AT" THE FACILITY, "THIS TIME INVOLVING A FEMALE PT. THIS INCIDENT OCCURRED ON AUGUST 10, 1998. THIS WAS A ROUTINE REMOVAL OF A FOLEY CATHETER PRIOR TO DISCHARGE FROM THE HOSP. THE CATHETER HAD BEEN INSERTED ON AUGUST 6TH AND HAD BEEN INDWELLING FOR ONLY 4 DAYS. THE PREPACKAGED KIT WAS USED WHEN THE CATHETER WAS INSERTED. AGAIN, BARD WAS NOTIFIED REGARDING THIS INCIDENT. A QUESTIONNAIRE WAS FAXED TO US FROM BARD WHICH WAS ANSWERED AND RETURNED. WE THEN ALSO REC'D A LETTER FROM BARD WITH AN ARTICLE "FOLEY CATHETER INFLATION/DEFLATION GUIDELINES" AND "WHEN A FOLEY CATHETER WON'T DEFLATE". THIS ARTICLE WAS DISTRIBUTED TO ALL NURSING SUPERVISORS AND NURSE MANAGERS TO RELAY INFO TO ALL NURSING STAFF AT ALL OF OUR HOSPITALS. FORTUNATELY, WE HAVE HAD NO SERIOUS OCCURRENCES DUE TO THESE DEFECTS AT THIS POINT; HOWEVER, AS I STATED BEFORE, I DO FEEL THERE IS A POTENTIAL FOR A SERIOUS ADVERSE EVENT TO OCCUR. WE ARE STAYING ON TOP OF THIS SITUATION AND WILL BE IN CONTINUOUS CONTACT WITH BARD UNTIL WE GET THE PROBLEM RESOLVED OR DECIDE TO CHANGE VENDORS".

    Description of Event or Problem · 3

    RPTR WRITES, "PLEASE NOTE THIS IS ONLY AN "FYI" LETTER IN CASE YOU HAVE BEEN NOTIFIED OF ANY OTHER SITUATIONS WHICH ARE SIMILAR TO THE FOLLOWING. WE HAVE HAD NO SERIOUS EVENTS OCCUR AS A RESULT, BUT FEEL THERE IS POTENTIAL. OVER THE PAST FEW MONTHS WE HAVE HAD PROBLEMS WITH DEFECTS IN OUR BARD FOLEY CATHETERS USED AT" THE FACILITY, "AND ONE OF OUR AFFILIATE FACILITIES". THE THIRD INCIDENT OCCURRED AT" THE AFFILIATE FACILITY "ON AUGUST 19TH. AGAIN, A DEFECTED FOLEY WOULD NOT DEFLATE. FORTUNATELY, WE HAVE HAD NO SERIOUS OCCURRENCES DUE TO THESE DEFECTS AT THIS POINT; HOWEVER, AS I STATED BEFORE, I DO FEEL THERE IS A POTENTIAL FOR A SERIOUS ADVERSE EVENT TO OCCUR. WE ARE STAYING ON TOP OF THIS SITUATION AND WILL BE IN CONTINUOUS CONTACT WITH BARD UNTIL WE GET THE PROBLEM RESOLVED OR DECIDE TO CHANGE VENDORS."

    Description of Event or Problem · 4

    RPTR WRITES, "PLEASE NOTE THIS IS ONLY AN "FYI" LETTER IN CASE YOU HAVE BEEN NOTIFIED OF ANY OTHER SITUATIONS WHICH ARE SIMILAR TO THE FOLLOWING. WE HAVE HAD NO SERIOUS EVENTS OCCUR AS A RESULT, BUT FEEL THERE IS POTENTIAL. OVER THE PAST FEW MONTHS WE HAVE HAD PROBLEMS WITH DEFECTS IN OUR BARD FOLEY CATHETERS USED AT" THE FACILITY, "AND ONE OF OUR AFFILIATE FACILITIES. OUR LATEST INCIDENT OCCURRED ON SEPTEMBER 7TH. THIS WAS A PT WHO ATTEMPTED TO PULL HIS FOLEY CATHETER OUT HIMSELF AND WAS UNSUCCESSFUL. OUR NURSES THEN TRIED TO DEFLATE THE FOLEY IN ORDER TO REMOVE IT AND AGAIN, THIS PROVED UNSUCCESSFUL. WHEN I REC'D THE CATHETER, THE BULB WAS STILL INFLATED AND INTACT. OUR UROLOGIST WAS NOTIFIED AND CONSULTED. I WAS IMMEDIATELY NOTIFIED BY NURISNG OF THE SITUATION AND CALLED BARD. I WAS UNABLE TO SPEAK WITH ANYONE AT THAT TIME; THEREFORE, I LEFT A MESSAGE. THE NEXT MORNING I STILL HAD NO RETURN PHONE CALL. I CALLED AGAIN AND ASKED TO SPEAK WITH WHO I HAD BEEN CORRESPONDING WITH REGARDING THE PREVIOUS INCIDENTS. SHE STATED SHE WAS GOING TO FAX ME ANOTHER QUESTIONNAIRE AND SOMEONE WOULD BE GETTING IN CONTACT WITH ME. SHE ALSO STATED THEY WERE NOT HAVING A PROBLEM PRIOR TO THIS. I TOLD HER WE WERE DISCUSSING CHANGING VENDORS DUE TO THIS PROBLEM. FORTUNATELY, WE HAVE HAS NO SERIOUS OCCURRENCES DUE TO THESE DEFECTS AT THIS POINT; HOWEVER, AS I STATED BEFORE, I DO FEEL THERE IS A POTENTIAL FOR A SERIOUS ADVERSE EVENT TO OCCUR. WE ARE STAYING ON TOP OF THIS SITUATION AND WILL BE IN CONTACT WITH BARD UNTIL WE GET THE PROBLEM RESOLVED OR DECIDE TO CHANGE VENDORS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD FOLEY CATHETER FOLEY CATHETER KOD C.R. BARD, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other
    2 NO INFO Other
    3 NO INFO Other
    4 NO INFO Other