BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETY SYRINGE

    MDR report key: 13197024 · Received January 7, 2022

    Report

    Report Number
    2243072-2021-03055
    Event Type
    Malfunction
    Date Received
    January 7, 2022
    Date of Event
    December 12, 2021
    Report Date
    February 1, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. 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. 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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 12/17/2021. H.6. INVESTIGATION: UNFORTUNATELY A LOT NUMBER COULD NOT BE SUBMITTED FOR THIS COMPLAINT, AND COULD NOT BE DETERMINED FROM THE PHOTOGRAPHS PROVIDED. PREVENTING OUR INVESTIGATION TEAM FROM CONDUCTING A DEVICE HISTORY REVIEW. A SAMPLE WAS RETURNED TO OUR FACILITY FOR EVALUATION AND TESTING. OUR ENGINEERS NOTED THAT THE RETURNED SYRINGE WAS EASILY SEPARATED FROM HE NEEDLE. THE ISSUE HASS BEEN CONFIRMED. CLOSER INSPECTION OF THE SYRINGE FOUND THAT ALL DIMENSIONS WERE WITHIN SPECIFICATION, AND NO PHYSICAL ABNORMALITIES COULD BE DETECTED. OUR ENGINEERS NOTED THAT THE PROVIDED NEEDLE IS MANUFACTURED BY ANOTHER COMPANY, AFTER REPLACING THE NEEDLE OUR ENGINEERS PERFORMED FUNCTIONAL TESTING OF THE DEVICE AND WERE UNABLE TO DETECT ANY SEPARATION UNDER PRODUCT SPECIFICATIONS. ADDITIONAL TESTING WAS PERFORMED ON RETAINED SAMPLES FOR RELATED LOTS WITH IDENTICAL RESULTS. UNFORTUNATELY, WITHOUT THE ABILITY TO REVIEW THE REPORTED FAILURE MODE OUR ENGINEERS WERE NOT ABLE TO ASSOCIATE THE ROOT CAUSE FOR THIS EVENT WITH THE MANUFACTURING PROCESS. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. 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. 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 · 0

    IT WAS REPORTED WHEN USING THE BD SAFETY SYRINGE THE SYRINGE AND NEEDLE WAS EASILY SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE "SYRINGE AND NEEDLE ARE EASILY SEPARATED."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD SAFETY SYRINGE THE SYRINGE AND NEEDLE WAS EASILY SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE "SYRINGE AND NEEDLE ARE EASILY SEPARATED.".

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD SAFETY SYRINGE THE SYRINGE AND NEEDLE WAS EASILY SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE "SYRINGE AND NEEDLE ARE EASILY SEPARATED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2500130 BD SAFETY SYRINGE PISTON SYRINGE FMF BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown