BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD ACCESS SYSTEMS, INC., PORT ACCESS KIT

    MDR report key: 21138431 · Received January 10, 2025

    Report

    Report Number
    MW5164581
    Event Type
    Injury
    Date Received
    January 10, 2025
    Date of Event
    December 12, 2024
    Report Date
    January 10, 2025
    Manufacturer
    CARDINAL HEALTH 200, LLC.
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PATIENT POWERPORT WAS ACCESSED WITH NEEDLE OBTAINED IN KIT. NURSE WAS UNABLE TO BREAK THROUGH THE SKIN. NEEDLE BENT. A SECOND KIT WAS OBTAINED WITH THE SAME LOT NUMBER AND ONCE AGAIN THE NEEDLE BEVEL FELT VERY DULL AND NURSE HAD DIFFICULTY INSERTING. WITH A LITTLE MORE PRESSURE NEEDLE SUCCESSFUL WENT THROUGH THE SKIN TO ACCESS PATIENT POWER PORT BUT WITH EACH INSERTION WITH BOTH KITS IT WAS VERY DIFFICULT TO GO THROUGH PATIENT SKIN. NO HARM WAS CAUSED TO PT OTHER THAN REPORTING LOCAL PAIN. PT WAS ABLE TO INITIATE AND COMPLETE INFUSE. I DO BELIEVE THE DEFICIENCY WAS WITH THE NEEDLE. (B)(4) WAS COMPLETED SUPERVISOR NOTIFIED AND THIS DOCUMENT COMPLETED AND EMAILED TO QUALITY STAFF. THE KITS WITH THE AFFECTED LOT NUMBERS OUR ISOLATED IN QUALITY CONTROL DEPARTMENT. THERE HASN'T BEEN ANY OTHER ISSUES WITH THIS PRODUCT (B)(6) IS THE POINT OF CONTACT. (B)(6) ALSO KNOW ABOUT THIS INCIDENT. THE SAFETY MANAGER IS (B)(6). I'VE SPOKEN TO OUR SUPPLIER. CARDINAL HEATH, AND OUR CASE NUMBER IS (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FOR REPORT MW5164581 ON 01-30-2025. ADDITIONAL DOCUMENTS AND UPDATED B5 TEXT. IN ADDITION TO THE ABOVE SUMMARY, MS. (B)(6) REPORTED THAT THE INCIDENT OCCURRED ON (B)(6) 2024 IN INTERNAL MEDICINE INFUSION SERVICES. SHE ALSO VERIFIED THAT THE INDIVIDUAL PERFORMING THE PROCEDURE WAS WELL TRAINED ¿NURSE OF 18.5 EXPERIENCE AND ACCESSES THIS PATIENT ONCE WEEKLY FOR INFUSIONS¿. SHE STATED THAT FOR BOTH KITS USED ¿THE BEVEL OF THE NEEDLE FELT EXTREMELY DULL¿. NO PHOTOS ARE AVAILABLE. THE DEFECTIVE NEEDLES WERE DISCARDED. THE DEFECTIVE ITEMS (KITS) WERE RETURNED TO THE VENDOR, (B)(4), CASE NO. (B)(4). CONTACTED BD AT [email protected] TO FOLLOW UP ON THE STATUS OF ANY INVESTIGATION. BD RESPONDED WITH THEIR REF NUMBERS FOR THIS COMPLAINT; (B)(4). THEY STATED THAT THE INVESTIGATION IS STILL PENDING. ¿ONCE THE INVESTIGATION IS COMPLETE, A CLOSURE LETTER WILL BE SENT TO YOUR ATTENTION WITH THE INVESTIGATION DETAILS.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498688 BARD ACCESS SYSTEMS, INC., PORT ACCESS KIT SET, ADMINISTRATION, INTRAVASCULAR FPA CARDINAL HEALTH 200, LLC. REJU0240

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown