BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ LUER-LOK SYRINGE 60 ML

    MDR report key: 13349529 · Received January 25, 2022

    Report

    Report Number
    1911916-2022-00024
    Event Type
    Malfunction
    Date Received
    January 25, 2022
    Date of Event
    January 6, 2022
    Report Date
    January 28, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1113366 MEDICAL DEVICE EXPIRATION DATE: 2026-03-31. DEVICE MANUFACTURE DATE: 2021-04-23. MEDICAL DEVICE LOT #: 1091333 . MEDICAL DEVICE EXPIRATION DATE: 2026-03-31 . DEVICE MANUFACTURE DATE: 2021-04-01 . 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 ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2022-01-27. H6: INVESTIGATION SUMMARY IT WAS REPORTED THE CUSTOMER SAW A LUBRICATION DRIPPING ON THE INSIDE OF THE BARREL OF THE SYRINGE AND ON THE STOPPER. TO AID IN THE INVESTIGATION, NINE SAMPLES IN SEALED PLASTIC BAGS AND NINE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. IN THE NINE PHOTOS PROVIDED SHOW SYRINGES AND PLUNGER RODS OUT OF THE SYRINGE BARREL. THE PHOTOS SHOW THE RUBBER STOPPER ALL THE WAY DOWN TOUCHING THE BOTTOM PART OF THE SYRINGE BARREL. WHEN THIS CONDITION IS CREATED, IT IS NORMAL TO NOTICE THE SILICONE. THE SILICONE IS MEDICAL GRADE AND IS APPLIED TO THE SYRINGE BARREL INNER WALL AND TO THE RUBBER STOPPER TO MOVE THE RUBBER STOPPER-PLUNGER ROD SMOOTHLY. IT COULD BE POSSIBLE THE CUSTOMER WAS NOT AWARE THE SYRINGES HAVE MEDICAL GRADE SILICONE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301035, LOT NUMBERS 1113366 AND 1091333. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THESE LOTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THESE LOTS. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD¿ LUER-LOK SYRINGES 60 ML EXPERIENCED FOREIGN MATTER IN THE DEVICE CANNULA AND FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CALLER IS SEEING A LUBRICATION DRIPPING ON THE INSIDE OF THE BARREL OF THE SYRINGE AND ON THE STOPPER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD¿ LUER-LOK SYRINGES 60 ML EXPERIENCED FOREIGN MATTER IN THE DEVICE CANNULA AND FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CALLER IS SEEING A LUBRICATION DRIPPING ON THE INSIDE OF THE BARREL OF THE SYRINGE AND ON THE STOPPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1115178 BD¿ LUER-LOK SYRINGE 60 ML PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown