BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK TIP SYRINGE

    MDR report key: 12520422 · Received September 23, 2021

    Report

    Report Number
    1911916-2021-01020
    Event Type
    Malfunction
    Date Received
    September 23, 2021
    Date of Event
    August 27, 2021
    Report Date
    September 24, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903028307
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 9/23/2021. H.6. INVESTIGATION: IT WAS REPORTED THAT THERE IS A BOX WHERE THE STERILITY OF THE PACKAGES HAVE BEEN COMPROMISED. TO AID IN THE INVESTIGATION, TWO SHELF BOXES, EACH WITH FORTY-EIGHT UNITS, FOR A TOTAL OF NINETY-SIX UNITS IN PACKAGING BLISTERS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. THE PACKAGING BLISTERS ARE IN SETS OF FOUR AND EACH SET HAS ONE PACKAGING BLISTER WITH AN OPEN SEAL. THE OPEN PACKAGING BLISTER IS AT ONE OF THE SIDES IN EACH SET. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD BE POSSIBLE DURING THE PACKAGING PROCESS IF, DURING THE SLITTING OPERATION, A PROCESS VARIATION OCCURRED INDUCING THE PACKAGING WEB BEING CUT SHORT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302830, LOT NUMBER 1180467. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THE PACKAGING PROCESS WAS REVIEWED. THE SETTINGS AND ADJUSTMENTS WERE CORRECT. THE SLITTING PROCESS WAS WORKING CORRECTLY. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 12 BD LUER-LOK¿ TIP SYRINGES WERE NOT SEALED CORRECTLY IN THE PACKAGING, COMPROMISING THEIR STERILITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE 20 CC SYRINGES IN A BOX WHERE THE STERILITY PACKAGES HAVE BEEN COMPROMISED. WE CANNOT USE THESE NONSTERILE SYRINGES." "NOT SURE IF YOU NEED TO REPORT THIS OR NOT. THE 1ST SYRINGE IN EVERY ROW ISN'T SEALED CORRECTLY THUS NOT STERILE. THERE ARE 12 IN THIS BOX."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 12 BD LUER-LOK¿ TIP SYRINGES WERE NOT SEALED CORRECTLY IN THE PACKAGING, COMPROMISING THEIR STERILITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE 20 CC SYRINGES IN A BOX WHERE THE STERILITY PACKAGES HAVE BEEN COMPROMISED. WE CANNOT USE THESE NONSTERILE SYRINGES." "NOT SURE IF YOU NEED TO REPORT THIS OR NOT. THE 1ST SYRINGE IN EVERY ROW ISN'T SEALED CORRECTLY THUS NOT STERILE. THERE ARE 12 IN THIS BOX.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1415419 BD LUER-LOK TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 302830 1180467 30382903028307

    Patients

    Seq Age Sex Outcome Treatment
    1