BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREWICK MALE EXTERNAL CATHETER KIT

    MDR report key: 15371514 · Received September 7, 2022

    Report

    Report Number
    1018233-2022-06974
    Event Type
    Malfunction
    Date Received
    September 7, 2022
    Date of Event
    August 15, 2022
    Report Date
    November 21, 2022
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    NZU
    UDI-DI
    00801741219153
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. THE DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE ¿OPERATOR ERROR". THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A LABELING REVIEW WAS NOT REQUIRED BECAUSE A REVIEW OF THE LABEL COULD NOT HAVE PREVENTED THIS ISSUE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUREWICK MALE EXTERNAL CATHETER WAS TRIALED THE PREVIOUS WEEK AND A RECAP CALL WAS HELD WITH THE KEY DECISION MAKERS. ONE OF THE DECISION MAKERS MADE A POINT TO CALL OUT THE SHARP EDGES IN THE BLUE PORT AND STATED THAT THIS WAS A PATIENT SAFETY CONCERN. IN ONE INSTANCE, THE BLUE PORT WAS BETWEEN A PATIENT'S LEGS AND INDENTIONS WERE LEFT. THEY FELT THAT IF IT HAD BEEN LEFT LONGER IT WOULD HAVE CAUSED A PRESSURE INJURY. TO EMPHASIZE THIS CONCERN, THEY MENTIONED ONE OF THEIR NURSES REPORTED FEELING LIKE THE BLUE PORT CUT THEM WHEN THEY WERE CONNECTING IT TO SUCTION. IN FACT, IT DID NOT CUT THEM BUT HIGHLIGHTED THE SHARPNESS OF THE PORT. THE AFFECTED LOTS WERE 5905406 AND UNK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUREWICK MALE EXTERNAL CATHETER WAS TRIALED THE PREVIOUS WEEK AND A RECAP CALL WAS HELD WITH THE KEY DECISION MAKERS. ONE OF THE DECISION MAKERS MADE A POINT TO CALL OUT THE SHARP EDGES IN THE BLUE PORT AND STATED THAT THIS WAS A PATIENT SAFETY CONCERN. IN ONE INSTANCE, THE BLUE PORT WAS BETWEEN A PATIENT'S LEGS AND INDENTIONS WERE LEFT. THEY FELT THAT IF IT HAD BEEN LEFT LONGER IT WOULD HAVE CAUSED A PRESSURE INJURY. TO EMPHASIZE THIS CONCERN, THEY MENTIONED ONE OF THEIR NURSES REPORTED FEELING LIKE THE BLUE PORT CUT THEM WHEN THEY WERE CONNECTING IT TO SUCTION. IN FACT, IT DID NOT CUT THEM BUT HIGHLIGHTED THE SHARPNESS OF THE PORT. THE AFFECTED LOTS WERE (BATCH# NGGTY113, BATCH# UNK).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1737940 PUREWICK MALE EXTERNAL CATHETER KIT PUREWICK MALE EXTERNAL CATHETER KIT NZU C.R. BARD, INC. (COVINGTON) -1018233 PWM030 NGGTY113 00801741219153

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other