BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALLBORE 6 INCH EXT VLV

    MDR report key: 11968158 · Received June 9, 2021

    Report

    Report Number
    9616066-2021-51285
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Date of Event
    May 13, 2021
    Report Date
    July 16, 2021
    Product Code
    FPA
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THE MATERIAL# WAS UPDATED, AND THE FOLLOWING INFORMATION HAS BEEN CORRECTED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE SMALLBORE 6 INCH EXT VLV COULD NOT BE PRIMED DUE TO BLOCKAGE/OCCLUSION. THIS OCCURRED ONCE EACH IN LOTS 20126085 AND 20096333, TWICE IN AN UNKNOWN LOT, AND 12 TIMES IN LOT 20125797. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL #: 20039E BATCH/ LOT #: 20126085 QTY. 1. BATCH/ LOT #: 20096333 QTY. 1. BATCH/ LOT #: 21016564 QTY. 2. BATCH/ LOT #: 20125797 QTY. 12. 16 IN TOTAL". "SAME SMARTSITE ISSUE THAT HAS BEEN HAPPENING, " UNABLE TO PRIME"" D.1. MEDICAL DEVICE BRAND NAME: SMALLBORE 6 INCH EXT VLV . THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 20126085 . D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-12-18. H.4. DEVICE MANUFACTURE DATE: 2020-12-09. D.4. MEDICAL DEVICE LOT #: 20096333. D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-09-16. H.4. DEVICE MANUFACTURE DATE: 2020-09-10 . D.4. MEDICAL DEVICE LOT #: 20125797. D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-12-08. H.4. DEVICE MANUFACTURE DATE: 2020-12-04. D.4. MEDICAL DEVICE LOT #: UNKNOWN. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. D.4. MEDICAL DEVICE LOT #: UNKNOWN. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. D.4. THE REPORTED LOT # 21016564 WAS NOT FOUND FOR THE REPORTED CATALOG # 20039E. D.5. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.5. PMA / 510(K)#: K960280.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF OCCLUSION WHEN PRIMING 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 TC10009278 BECAUSE A VALID LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED WITHOUT A FAILURE INVESTIGATION. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SMALLBORE 6 INCH EXT VLV COULD NOT BE PRIMED DUE TO BLOCKAGE/OCCLUSION. THIS OCCURRED ONCE EACH IN LOTS 20126085, 20096333, AND AN UNSPECIFIED LOT, TWICE IN ANOTHER UNKNOWN LOT, AND 12 TIMES IN LOT 20125797. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL #: 20039E BATCH/ LOT #: 20126085 QTY. 1. BATCH/ LOT #: 20096333 QTY. 1. BATCH/ LOT #: 21016564 QTY. 2. BATCH/ LOT #: 20125797 QTY. 12. 16 IN TOTAL". "SAME SMARTSITE ISSUE THAT HAS BEEN HAPPENING, " UNABLE TO PRIME"".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CAP SAFETY SMARTSITE COULD NOT BE PRIMED DUE TO BLOCKAGE/OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SAME SMARTSITE ISSUE THAT HAS BEEN HAPPENING, "UNABLE TO PRIME"".

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAP SAFETY SMARTSITE COULD NOT BE PRIMED DUE TO BLOCKAGE/OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SAME SMARTSITE ISSUE THAT HAS BEEN HAPPENING, " UNABLE TO PRIME.""

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864329 SMALLBORE 6 INCH EXT VLV INTRAVASCULAR ADMINISTRATION SET FPA SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1