BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK TIP SYRINGE

    MDR report key: 10418283 · Received August 17, 2020

    Report

    Report Number
    1213809-2020-00539
    Event Type
    Malfunction
    Date Received
    August 17, 2020
    Date of Event
    July 27, 2020
    Report Date
    August 19, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE PHOTO OF A 3ML SYRINGE IN A FULLY SEALED BLISTER PACK WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THERE WAS NO VISIBLE PRINT ON THE SYRINGE, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. A POTENTIAL ROOT CAUSE FOR THE MISSING SCALE DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. THE AQL FOR MISSING PRINT IS 0.25%. (B)(4). NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 0150246 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ TIP SYRINGE HAD NO SCALE MARKINGS ON IT PRIOR TO USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE GOT A REPORT EARLIER TODAY THAT THE FLOORS HAVE BEEN FINDING, OVER THE LAST COUPLE OF WEEKS, THAT SOME OF THE 3CC SYRINGES DON'T HAVE ANY VOLUME MARKINGS ON THEM. THE ONE THEY FOUND WAS LOT# 0150246."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD LUER-LOK¿ TIP SYRINGE HAD NO SCALE MARKINGS ON IT PRIOR TO USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE GOT A REPORT EARLIER TODAY THAT THE FLOORS HAVE BEEN FINDING, OVER THE LAST COUPLE OF WEEKS, THAT SOME OF THE 3CC SYRINGES DON'T HAVE ANY VOLUME MARKINGS ON THEM. THE ONE THEY FOUND WAS LOT# 0150246."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876564 BD LUER-LOK TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309657 0150246 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other