BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ LUER-LOK¿ SYRINGE

    MDR report key: 13869901 · Received March 23, 2022

    Report

    Report Number
    3003152976-2022-00116
    Event Type
    Malfunction
    Date Received
    March 23, 2022
    Date of Event
    March 3, 2022
    Report Date
    May 19, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2110708. MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2026. DEVICE MANUFACTURE DATE: 08-OCT-2021 . MEDICAL DEVICE LOT #: 2110134. . MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2026. DEVICE MANUFACTURE DATE: 26-OCT-2021. MEDICAL DEVICE LOT #: 2111129. MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2026. DEVICE MANUFACTURE DATE: 10-NOV-2021. 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

    H.6. INVESTIGATION: THREE PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, SILICONE CAN BE OBSERVED ALONG WITH A BLACK FOREIGN MATTER ON THE PLUNGER OF THE SYRINGE. WITHOUT THE PHYSICAL SAMPLE TO EVALUATE, WE CANNOT DEFINITIVELY IDENTIFY THE BLACK MATTER, THEREFORE THE EXACT ORIGIN CANNOT BE ESTABLISHED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR SUSPECTED LOTS 2110708, 2110134, AND 2111129, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES 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. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, SILICONE CAN BE VISIBLE DUE TO ISSUES RELATED TO POOR DISTRIBUTION INSIDE THE BARREL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD PLASTIPAK¿ LUER-LOK¿ SYRINGES, POSSIBLY FROM LOTS 2110708, 2110134, OR 2111129, HAD ISSUES WITH VISIBLE SILICONE SETTLING AT THE TOP OF THEIR PLUNGERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD TWO 30ML SYRINGES WITH A FAULTY PLUNGER - A QUALITY ISSUE WITH BLACK TOP OF THE PLUNGER." "I BELIEVE IT WAS THE SILICONE IN THE BARREL COMMING OFF AND SETTLED AT THE TOP OF THE PLUNGER."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD PLASTIPAK¿ LUER-LOK¿ SYRINGES, POSSIBLY FROM LOTS 2110708, 2110134, OR 2111129, HAD ISSUES WITH VISIBLE SILICONE SETTLING AT THE TOP OF THEIR PLUNGERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD TWO 30ML SYRINGES WITH A FAULTY PLUNGER - A QUALITY ISSUE WITH BLACK TOP OF THE PLUNGER." "I BELIEVE IT WAS THE SILICONE IN THE BARREL COMMING OFF AND SETTLED AT THE TOP OF THE PLUNGER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070048 BD PLASTIPAK¿ LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE SECTION H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown