BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-CONN W/LL & 1 VLV PORT

    MDR report key: 11646221 · Received April 9, 2021

    Report

    Report Number
    2243072-2021-01083
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 12, 2021
    Report Date
    April 13, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    UDI-DI
    27613203021665
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF DOCUMENTATION ERROR- LABEL CONTENT INCORRECT COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL 20041E BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A T-CONN W/LL & 1 VLV PORT HAD INCORRECT LABEL INFORMATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT CUSTOMER RECEIVED ITEM 20041E WHICH IS WHAT WAS ORDERED. HOWEVER THEY RECEIVED 406703 INSIDE INSTEAD. VERBATIM: HELLO, BECTON DICKINSON. PURCHASE ORDER # 1520601280-1520. REQUISITION # 354065. INVOICE # 9107537251. VENDOR CATALOG # 20041E. DESCRIPTION: SET IV EXT SM BORE T 1 W 6IN. LAWSON ITEM # 212353. QUANTITY: 1 CA. REASON: MISPICK. ORDERED: 1 CA L: 212353 SET IV EXT SM BORE T 1 W 6IN. RECEIVED: 1 CA L: 406703 SET EXT PMP LL 336IN 8ML SM BORE 2PC M LL. THE ABOVE INFORMATION IS A REQUEST TO RETURN PRODUCT. ARE WE ABLE TO RETURN FOR CREDIT THE LABELS SHOWS YOU RECEIVED ITEM 20041E WHICH IS WHAT WAS ORDERED. DOES THE LABEL SAY 20041E HOWEVER YOU RECEIVED 406703 INSIDE INSTEAD? YES, THAT IS THE CASE. EVEN THOUGH THE STICKER SAYS THE CORRECT PRODUCT WE RECEIVED THE INCORRECT PRODUCT IN THE BOX. PLEASE REVIEW IF PRODUCT COMPLAINT CUSTOMER PLACED ORDER FOR ITEM 20041E BUT RECEIVED ITEM 406703 IN BOX."

    Additional Manufacturer Narrative · 1

    "UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A T-CONN W/LL & 1 VLV PORT HAD INCORRECT LABEL INFORMATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT CUSTOMER RECEIVED ITEM 20041E WHICH IS WHAT WAS ORDERED. HOWEVER THEY RECEIVED 406703 INSIDE INSTEAD. VERBATIM: HELLO, BECTON DICKINSON (B)(4). THE ABOVE INFORMATION IS A REQUEST TO RETURN PRODUCT. ARE WE ABLE TO RETURN FOR CREDIT? THE LABELS SHOWS YOU RECEIVED ITEM 20041E WHICH IS WHAT WAS ORDERED. DOES THE LABEL SAY 20041E HOWEVER YOU RECEIVED 406703 INSIDE INSTEAD? YES, THAT IS THE CASE. EVEN THOUGH THE STICKER SAYS THE CORRECT PRODUCT WE RECEIVED THE INCORRECT PRODUCT IN THE BOX. PLEASE REVIEW IF PRODUCT COMPLAINT CUSTOMER PLACED ORDER FOR ITEM 20041E BUT RECEIVED ITEM 406703 IN BOX."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542822 T-CONN W/LL & 1 VLV PORT INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 20041E UNKNOWN 27613203021665

    Patients

    Seq Age Sex Outcome Treatment
    1