BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ THREADED LOCK CANNULA

    MDR report key: 14317452 · Received May 7, 2022

    Report

    Report Number
    1213809-2022-00266
    Event Type
    Malfunction
    Date Received
    May 7, 2022
    Date of Event
    April 14, 2022
    Report Date
    May 20, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903033691
    PMA / PMN Number
    K011858
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY ONE CARTON BOX CONTAINING 92 SEALED PACKAGES AND FIVE PHOTOS OF THREAD-LOCK CANNULA (P/N 303369) WERE RECEIVED AND EVALUATED. SEVENTY FIVE OF THE SAMPLES HAD A LIGHT SEAL AT THE TOP OF THE PEEL TAB EFFECTING EASE OF USE FOR OPENING THE PEEL TAB. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE CLEAN PEEL DEFECT IS ASSOCIATED WITH THE PACKAGING PROCESS. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BATCH 1082816 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED BATCH NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 80 BD¿ THREADED LOCK CANNULAS HAD POOR PACKAGING PERFORATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "DEFECTIVE SEALING." VIA BDJ INVESTIGATION: "THE SEALING OF MANY PACKAGES WAS ENTIRELY CRIMPED".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 80 BD¿ THREADED LOCK CANNULAS HAD POOR PACKAGING PERFORATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "DEFECTIVE SEALING." VIA BDJ INVESTIGATION: "THE SEALING OF MANY PACKAGES WAS ENTIRELY CRIMPED"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253188 BD¿ THREADED LOCK CANNULA INTRAVASCULAR ADMINISTRATION SET FMI BECTON DICKINSON MEDICAL SYSTEMS 303369 1082816 30382903033691

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown