BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP SYRINGE

    MDR report key: 16261159 · Received January 28, 2023

    Report

    Report Number
    9614033-2023-00003
    Event Type
    Malfunction
    Date Received
    January 28, 2023
    Date of Event
    January 9, 2023
    Report Date
    April 25, 2023
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    00382903033102
    PMA / PMN Number
    K151766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 21-APR-2023. THIRTY THREE SAMPLES AND PHOTO RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL EVALUATION, CLEAR LIQUID IDENTIFIED AS SILICONE CAN BE OBSERVED IN THE FLUID PATH OF THE SYRINGES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOTS 2010094, 1286653, 1337265, 1337269, 2046956, 2193774 NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. LUBRICANT IS EMPLOYED DURING THE SYRINGE ASSEMBLY PROCESS TO LUBRICATE THE CYLINDERS IN THE SILICONE STATION. THE SILICONE EMPLOYED IN THIS PRODUCT IS A MEDICAL GRADE SILICONE AUTHORIZED FOR PRODUCT USE. SILICONE CONTENT TESTS ARE PERFORMED DURING THE MANUFACTURING PROCESS OF EACH LOT NUMBER. TESTING WAS PERFORMED ON THE SAMPLES, RESULTS VERIFIED AMOUNT OF SILICONE WAS WITH THE REQUIRED LIMITS. ACCORDING TO SILICONE CONTENT TEST PERFORMED WITH SAMPLES RECEIVED, AN EXCESS OF SILICONE CANNOT BE CONFIRMED. BASED ON THE INVESTIGATION RESULTS, NO MANUFACTURING RELATED DEFECTS COULD BE IDENTIFIED AND THEREFORE, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. H3 OTHER TEXT : SEE H10.

    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO CORRECTIONS: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT OIL/GREASE WAS FOUND INSIDE THE BD LUER-LOK¿ TIP SYRINGES BEFORE USE. THIS OCCURRED 33 TIMES EACH IN LOTS 1286653, 1337265, 1337269, 2019094, 2046956, AND 2193774. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 1286653. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2026. H.4. DEVICE MANUFACTURE DATE: 06-DEC-2021. D.4. MEDICAL DEVICE LOT #: 1337265 D.4. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2026 H.4. DEVICE MANUFACTURE DATE: 03-FEB-2022 D.4. MEDICAL DEVICE LOT #: 1337269 D.4. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2026 H.4. DEVICE MANUFACTURE DATE: 05-FEB-2022 D.4. MEDICAL DEVICE LOT #: 2019094 D.4. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2027 H.4. DEVICE MANUFACTURE DATE: 07-MAR-2022 D.4. MEDICAL DEVICE LOT #: 2046956 D.4. MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2027 H.4. DEVICE MANUFACTURE DATE: 14-MAR-2022 D.4. MEDICAL DEVICE LOT #: 2193774 D.4. MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2027 H.4. DEVICE MANUFACTURE DATE: 13-SEP-2022.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OIL/GREASE WAS FOUND INSIDE 33 BD LUER-LOK¿ TIP SYRINGES BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE SYRINGES HAVING OIL/GREASE INSIDE OF THEM AND THEY ARE UNSURE IF THEY ARE SAFE FOR USE.".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OIL/GREASE WAS FOUND INSIDE 33 BD LUER-LOK¿ TIP SYRINGES BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE SYRINGES HAVING OIL/GREASE INSIDE OF THEM AND THEY ARE UNSURE IF THEY ARE SAFE FOR USE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OIL/GREASE WAS FOUND INSIDE THE BD LUER-LOK¿ TIP SYRINGES BEFORE USE. THIS OCCURRED 33 TIMES EACH IN LOTS 1286653, 1337265, 1337269, 2019094, 2046956, AND 2193774. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE SYRINGES HAVING OIL/GREASE INSIDE OF THEM AND THEY ARE UNSURE IF THEY ARE SAFE FOR USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846287 BD LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO SEE H10 00382903033102

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown