BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML LS W/RED PLUNGER

    MDR report key: 11263739 · Received February 1, 2021

    Report

    Report Number
    8041187-2021-00060
    Event Type
    Malfunction
    Date Received
    February 1, 2021
    Date of Event
    January 7, 2021
    Report Date
    February 23, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: 2021-01-25. H6: INVESTIGATION SUMMARY: ONE ACTUAL SAMPLE AND ONE HUNDRED REPRESENTATIVE SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THIRTY REPRESENTATIVE SAMPLES WERE SUBJECTED TO THE BREAKOUT AND SUSTAINING FORCE TEST AND SHOWED THAT THE PLUNGER BREAKAGE AND SUSTAINING FORCE IS WITHIN THE PRODUCT SPECIFICATION. THIRTY REPRESENTATIVE SAMPLES WERE SUBJECTED TO THE SILICONE CONTENT DETERMINATION TEST AND SHOWED THAT THE SILICONE CONTENT FORCE IS WITHIN THE PRODUCT SPECIFICATION. THEREFORE, THE TEAM WAS NOT ABLE TO CONFIRM THE CUSTOMER EXPERIENCE. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM INVESTIGATION, THE ROOT CAUSE COULD NOT BE ESTABLISHED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 5ML LS W/RED PLUNGER PLUNGER WAS HARD TO USE. THIS OCCURRED ON 400 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLUNGER IS VERY HARD TO USE. WE HAVE HAD A BATCH OF THE ABOVE SYRINGES THAT THE PLUNGER IS VERY HARD TO USE. THE ANAESTHETISTS USE THIS PARTICULAR SYRINGE WHEN DELIVERING THE MUSCLE RELAXANT TO PATIENTS AND THE PLUNGER NEEDS TO SLIDE MORE EASILY. THE AFFECTED BATCH HAS BEEN REMOVED FROM THE SHELF. BRETT HAS LOCATED SOME WITH A DIFFERENT LOT NUMBER WHICH APPEAR TO BE FINE AND FILLED THEIR SPOT IN TG14.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 5ML LS W/RED PLUNGER WAS HARD TO USE. THIS OCCURRED ON 400 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLUNGER IS VERY HARD TO USE. WE HAVE HAD A BATCH OF THE ABOVE SYRINGES THAT THE PLUNGER IS VERY HARD TO USE. THE ANAESTHETISTS USE THIS PARTICULAR SYRINGE WHEN DELIVERING THE MUSCLE RELAXANT TO PATIENTS AND THE PLUNGER NEEDS TO SLIDE MORE EASILY. THE AFFECTED BATCH HAS BEEN REMOVED FROM THE SHELF. BRETT HAS LOCATED SOME WITH A DIFFERENT LOT NUMBER WHICH APPEAR TO BE FINE AND FILLED THEIR SPOT IN TG14.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153660 SYRINGE 5ML LS W/RED PLUNGER SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) 0169446

    Patients

    Seq Age Sex Outcome Treatment
    1