BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFANT CATH KIT

    MDR report key: 5224449 · Received November 15, 2015

    Report

    Report Number
    1018233-2015-00473
    Event Type
    Injury
    Date Received
    November 15, 2015
    Report Date
    December 5, 2015
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590
    Product Code
    FFH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    RECEIVED 1 UNOPENED INFANT CATHETER KIT IN THE ORIGINAL UNIT PACKAGING. VISUAL INSPECTION NOTED NO OBVIOUS DEFECTS. THE RECEIVED SAMPLE WAS EVALUATED ACCORDING TO THE MATERIAL LIST AND ALL COMPONENTS WERE FOUND TO BE WITHIN SPECIFICATIONS. NO FOREIGN MATTER OR DIRT WAS PRESENT ON THE SAMPLE. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE COMPLAINT WAS UNCONFIRMED AS THE DEVICE MET ALL SPECIFICATIONS. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "OPEN PACKAGE AND REMOVE PLASTIC WALLET. OPEN PLASTIC WALLET. PLACE INFANT IN SUPINE POSITION, THIGHS ABDUCTED. CLEANSE THE AREA AROUND THE MEATUS WITH POVIDINE-IODINE SWABS. PUT ON STERILE GLOVES. PLACE THE TIP OF THE CATHETER IN STERILE LUBRICANT AND CATHETERIZE PATIENT. AFTER URINE IS COLLECTED, PULL CATHETER OUT OF CAP. TIGHTEN CAP AND DEPRESS SPOUT. LABEL CENTRIFUGE TUBE IMPORTANT: USE PLASTIC WALLET AS STERILE FIELD. PULL CATHETER OUT OF CENTRIFUGE TUBE TO THE PROPER LENGTH IMMEDIATELY AFTER DONNING GLOVES. NOTE: IF URINE DOES NOT FLOW FREELY INTO THE TUBE, THE CAP STERILE UNLESS PACKAGE IS OPENED OR DAMAGED." (B)(4). 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 · 1

    IT WAS REPORTED THAT THE PATIENT ALLEGEDLY HAD A CULTURE TAKEN AND GRAM NEGATIVE RODS WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754448 INFANT CATH KIT INFANT CATHETER FFH PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 NGYJ1499

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention