BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVOL® INFANT CATH KIT

    MDR report key: 18388640 · Received December 22, 2023

    Report

    Report Number
    1018233-2023-09128
    Event Type
    Injury
    Date Received
    December 22, 2023
    Date of Event
    December 6, 2023
    Report Date
    April 29, 2024
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    FFH
    UDI-DI
    00801741045844
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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. 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.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE. THE CONDITIONS OF THE PHOTO SAMPLE DID NOT ALLOW FURTHER EVALUATION. A POTENTIAL ROOT CAUSE FOR THIS TYPE OF FAILURE COULD BE ¿INLET PORT OF THE CAP /CATHETER (FR.) THICKNESS OUT OF SPECIFICATION¿. HOWEVER, THERE WAS INSUFFICIENT INFORMATION TO CONFIRM THIS POTENTIAL ROOT CAUSE. 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: "WARNINGS: THE CATHETER SHOULD NEVER BE FORCED IF RESISTANCE IS FELT. TRAUMA TO THE BLADDER (FALSE PASSAGE) CAN BE PREVENTED BY ADEQUATELY LUBRICATING THE CATHETER AND STRETCHING THE PENIS TO STRAIGHTEN THE URETHRA. STERILE: STERILE UNLESS PACKAGE IS OPENED OR DAMAGED. CAUTION: FEDERAL (U.S.A.) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. CAUTION: READ ALL INSTRUCTIONS PRIOR TO USE. INDICATIONS: BLADDER CATHETERIZATION IS PERFORMED WHEN A STERILE URINE SAMPLE IS NEEDED AND A CLEAN CATCH SPECIMEN CANNOT BE OBTAINED." 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT HOW MUCH OF THE FOLEY CATHETER SHOULD BE LEFT IN THE TUBE WHEN USING IT TO OBTAIN A URINE SPECIMEN. AND REPORTED THAT THE INTERMITTENT CATHETER SOMETIMES A SMALLER SIZE COULD BE USED DUE TO IT JUST BEING FOR SPECIMEN COLLECTION. THE POSSIBLE LEAKING AROUND THE CATHETER WAS NOT AS GREAT OF A CONCERN IF NOT BEING PLACED AS AN INDWELLING. AND REPORTED THAT 5 FRENCH CATHETER KITS WERE VERY SECURE IN THE COLLECTION TUBE AND SOME RESISTANCE WHEN PULLING OUT THE CATHETER, WHILE THE 8 FRENCH FEMALE CATHETER KITS HAD VERY LITTLE RESISTANCE WHEN PULLING OUT THE CATHETER. IT DID NOT FALL OUT ON ITS OWN BUT TOOK VERY LITTLE PULL TO HAVE IT BECOME COMPLETELY DISLODGED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT HOW MUCH OF THE FOLEY CATHETER SHOULD BE LEFT IN THE TUBE WHEN USING IT TO OBTAIN A URINE SPECIMEN. AND REPORTED THAT THE INTERMITTENT CATHETER SOMETIMES A SMALLER SIZE COULD BE USED DUE TO IT JUST BEING FOR SPECIMEN COLLECTION. THE POSSIBLE LEAKING AROUND THE CATHETER WAS NOT AS GREAT OF A CONCERN IF NOT BEING PLACED AS AN INDWELLING. AND REPORTED THAT 5 FRENCH CATHETER KITS WERE VERY SECURE IN THE COLLECTION TUBE. AND SOME RESISTANCE WHEN PULLING OUT THE CATHETER, WHILE THE 8 FRENCH FEMALE CATHETER KITS HAD VERY LITTLE RESISTANCE WHEN PULLING OUT THE CATHETER. IT DID NOT FALL OUT ON ITS OWN BUT TOOK VERY LITTLE PULL TO HAVE IT BECOME COMPLETELY DISLODGED. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 19JAN2024, THEY DID NOT HAVE THE LOT NUMBERS FOR THE DEVICES AT CELEBRATION WHERE THE PRODUCT THAT LEAD TO PATIENT HARM WAS USED. BUT THE PRODUCT THAT THEY REVIEWED AND EXPERIENCED EASY MOVEMENT OF THE CATHETER WITHIN THE COLLECTION TUBE WAS (B)(6). MULTIPLE DIFFERENT LOT NUMBER OF THE INTERMITTENT 8 FRENCH CATH KIT HAVE BEEN LOOKED AT BETWEEN TWO CAMPUSES. THE SAME CONCERN WAS VOICED WITH THE EASE OF MOVEMENT WITH THE 8 FRENCH CATH WITHIN COLLECTION TUBE FOR ALL 8 FRENCH THAT WERE REVIEWED. THE 5 FRENCH HAS A TIGHTER FIT WITHIN THE COLLECTION TUBE AND TAKES GREATER EFFORT TO PULL IT OUT. THE PATIENT REQUIRED SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2288533 DAVOL® INFANT CATH KIT INFANT CATH KIT FFH C.R. BARD, INC. (COVINGTON) -1018233 UNK 00801741045844

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R