BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALE LUER SLIP 64 CAV.

    MDR report key: 11646132 · Received April 9, 2021

    Report

    Report Number
    2243072-2021-01071
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 14, 2021
    Report Date
    June 7, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION; D4: CATALOG # 1013-156-004; D4: LOT # UNKNOWN. THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-04-12. H6: INVESTIGATION SUMMARY: 6 SAMPLES OF THE 1013-156-004 MODEL WERE RECEIVED, A PRELIMINARY VISUAL INSPECTION WAS PERFORMED. SMALL CRACKS WERE IDENTIFIED IN ONLY 4 SAMPLES, NO ISSUES WERE DETECTED IN THE TWO REMAINING. DHR REVIEW COULD NOT BE COMPLETED DUE TO NO LOT NUMBER WAS REPORTED. SINCE THE FAILURE MODE COULD NOT BE REPLICATED, A CAUSE EFFECT WAS CONDUCTED, HOWEVER, SINCE THE DAMAGE IS IN THE OUTSIDE OF THE FLUID PATH, IT WAS CONSIDERED THAT AN EXTERNAL FORCE GENERATED THE DAMAGE, THEREFORE, THE ROOT CAUSE COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: 6 SAMPLES OF THE 1013-156-022 MODEL WERE RECEIVED, A PRELIMINARY VISUAL INSPECTION WAS PERFORMED. SMALL CRACKS WERE IDENTIFIED IN ONLY 4 SAMPLES, NO ISSUES WERE DETECTED IN THE TWO REMAINING. DHR REVIEW COULD NOT BE COMPLETED DUE TO NO LOT NUMBER WAS REPORTED. SINCE THE FAILURE MODE COULD NOT BE REPLICATED, A CAUSE EFFECT WAS CONDUCTED, HOWEVER, SINCE THE DAMAGE IS IN THE OUTSIDE OF THE FLUID PATH, IT WAS CONSIDERED THAT AN EXTERNAL FORCE GENERATED THE DAMAGE, THEREFORE, THE ROOT CAUSE COULD NOT BE CONFIRMED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MALE LUER SLIP 64 CAV. LEAKED AFTER THE IV WAS STARTED. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER SAYS THEY START LEAKING AFTER IV HAS BEEN STARTED IN PATIENT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MALE LUER SLIP 64 CAV. LEAKED AFTER THE IV WAS STARTED. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER SAYS THEY START LEAKING AFTER IV HAS BEEN STARTED IN PATIENT."

    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 IN AND (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 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 MALE LUER SLIP 64 CAV. LEAKED AFTER THE IV WAS STARTED. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER SAYS THEY START LEAKING AFTER IV HAS BEEN STARTED IN PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542960 MALE LUER SLIP 64 CAV. INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1