BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ 3ML SYRINGE

    MDR report key: 17761298 · Received September 15, 2023

    Report

    Report Number
    1213809-2023-01024
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Date of Event
    August 1, 2023
    Report Date
    October 25, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096572
    PMA / PMN Number
    K182589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. EXAMINATION OF THE ACTUAL PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    E.4.: THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 03AUG2023. MEDWATCH REPORT # MW5120695. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PLASTIPAK¿ 3ML SYRINGE THE DEVICE WAS CRACKED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A 3ML SYRINGES DISCOVERED TO BE CRACKED UPON MANIPULATING FOR IV STERILE COMPOUNDS. DEFECT LOT NUMBERS IDENTIFIED: 3103923, 3111336, 3118444 AND 3111348. CRACKED SYRINGES WERE NOT USED TO COMPLETE STERILE COMPOUNDS. REFERENCE REPORTS MW5120693, MW5120694, MW5120696.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PLASTIPAK¿ 3ML SYRINGE THE DEVICE WAS CRACKED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A 3ML SYRINGES DISCOVERED TO BE CRACKED UPON MANIPULATING FOR IV STERILE COMPOUNDS. DEFECT LOT NUMBERS IDENTIFIED: 3103923, 3111336, 3118444 AND 3111348. CRACKED SYRINGES WERE NOT USED TO COMPLETE STERILE COMPOUNDS. REFERENCE REPORTS MW5120693, MW5120694, MW5120696.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328678 BD PLASTIPAK¿ 3ML SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3118444 00382903096572

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown