BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARREL 3ML LL WWD WITH SIL NO LOGO BNS

    MDR report key: 10488064 · Received September 3, 2020

    Report

    Report Number
    1213809-2020-00597
    Event Type
    Malfunction
    Date Received
    September 3, 2020
    Date of Event
    August 12, 2020
    Report Date
    September 9, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY THREE PHOTOS AND SIX LOOSE 3ML BARRELS WERE RECEIVED AND EVALUATED. IT WAS OBSERVED IN THE PHOTOS AND PHYSICAL SAMPLES, THERE WAS A SMALL PERPENDICULAR SCRATCH PRESENT OUTSIDE THE GRAD LINES NEAR THE 0.5ML MARKING. THE SCRATCHES WERE APPROXIMATELY 0.25" IN LENGTH. ON ALL THE SAMPLES, THE SCRATCH APPEARED TO BE COSMETIC IN NATURE WITH NO EFFECT TO THE FORM FIT OR FUNCTION OF THE DEVICE, WHICH WAS ACCEPTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE SCRATCHED BARREL DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. IT WAS LIKELY DUE TO A BARREL CAUGHT IN THE GUIDE AND CONTACTING THE PRODUCT AS IT PASSED BY. SINCE THE DEFECTS OBSERVED ARE WITHIN THE ACCEPTABLE LIMITS, NO CORRECTIVE ACTIONS ARE NECESSARY. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9211905.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT (B)(4) BARREL 3ML LL WWD WITH SIL NO LOGO BNS WERE DAMAGED, BUT STILL OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT (B)(4) SYRINGES HAVE SCRACTHES/SLITS ON THE OUTSIDE WALL OF THE BARREL. RELATED TW# (B)(6) PER EMAIL: AGAIN, WE FOUND MORE UNITS WITH THIS CONDITION AND PRODUCTION HAS REQUESTED TO RETAIN ALL THE MATERIAL COMING FROM THIS LOT: 9211905. WE HAVE A TOTAL OF (B)(4)EAS."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. 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 111172 BARREL 3ML LL WWD WITH SIL NO LOGO BNS WERE DAMAGED, BUT STILL OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT (B)(4) SYRINGES HAVE SCRATCHES/SLITS ON THE OUTSIDE WALL OF THE BARREL. RELATED TW# (B)(4). PER EMAIL: AGAIN, WE FOUND MORE UNITS WITH THIS CONDITION AND PRODUCTION HAS REQUESTED TO RETAIN ALL THE MATERIAL COMING FROM THIS LOT: 9211905. WE HAVE A TOTAL OF (B)(4) EAS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950991 BARREL 3ML LL WWD WITH SIL NO LOGO BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9211905

    Patients

    Seq Age Sex Outcome Treatment
    1 Other