BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP

    MDR report key: 9355738 · Received November 21, 2019

    Report

    Report Number
    2243072-2019-02614
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    October 26, 2019
    Report Date
    December 2, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE MANUFACTURING LOCATION. THE FOLLOWING FIELDS HAVE BEEN UPDATED: MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON MEDICAL SYSTEMS MANUFACTURING LOCATION: BECTON DICKINSON MEDICAL SYSTEMS PMA / 510(K)#: K980987.

    Additional Manufacturer Narrative · 0

    CORRECTION: MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON MEDICAL SYSTEMS ¿ CANAAN, CT / 06018. MANUFACTURING LOCATION: BECTON DICKINSON MEDICAL SYSTEMS ¿ CANAAN, CT / 06018. INVESTIGATION SUMMARY: NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, SO WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS LOT NUMBER WAS UNKNOWN. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARTRIDGE LEAKED WITH USE OF THE BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP DURING THE LOADING PROCESS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTED CARTRIDGE WAS LEAKING DURING LOAD PROCESS. CUSTOMER STATED SHE IS NEW TO PUMP AND NOT CONFIDENT IN HER LOAD TECHNIQUE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARTRIDGE LEAKED WITH USE OF THE BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP DURING THE LOADING PROCESS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTED CARTRIDGE WAS LEAKING DURING LOAD PROCESS. CUSTOMER STATED SHE IS NEW TO PUMP AND NOT CONFIDENT IN HER LOAD TECHNIQUE."

    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 AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. THERE WERE MULTIPLE PMA / 510(K)#S REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: PMA / 510(K)#: K980987 ((B)(4)). PMA / 510(K)#: K151766 ((B)(4)). 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 CARTRIDGE LEAKED WITH USE OF THE BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP DURING THE LOADING PROCESS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTED CARTRIDGE WAS LEAKING DURING LOAD PROCESS. CUSTOMER STATED SHE IS NEW TO PUMP AND NOT CONFIDENT IN HER LOAD TECHNIQUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154370 BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other