BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML S/T BNS

    MDR report key: 10115182 · Received June 3, 2020

    Report

    Report Number
    1213809-2020-00367
    Event Type
    Malfunction
    Date Received
    June 3, 2020
    Date of Event
    November 7, 2019
    Report Date
    June 9, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO OF A LOOSE 1ML SYRINGE WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THERE WAS NO SCALE MARKINGS PRESENT AND TWO SMALL INK SMEARS ON THE SYRINGE WITH ONE AT THE BOTTOM AND ONE NEAR THE TOP UNDER THE STEP. THE MISSING SCALE WAS REJECTABLE PER PRODUCT SPECIFICATION. A POTENTIAL ROOT CAUSE FOR THE MISSING SCALE DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. DHR WAS PERFORMED. (B)(4). NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 9180282 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 1ML S/T BNS WAS MISSING SCALE MARKINGS. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 301025 BATCH NO: UNKNOWN (MAYBE 9064854 OR 9180282) IT WAS REPORTED THAT THE SYRINGE WAS MISSING SCALE MARKINGS.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9064854. MEDICAL DEVICE EXPIRATION DATE: 2024-02-29. DEVICE MANUFACTURE DATE: 2019-03-05. MEDICAL DEVICE LOT #: 9180282. MEDICAL DEVICE EXPIRATION DATE: 2024-05-31. DEVICE MANUFACTURE DATE: 2019-06-29. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 1ML S/T BNS WAS MISSING SCALE MARKINGS. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 301025, BATCH NO: UNKNOWN (MAYBE 9064854 OR 9180282). IT WAS REPORTED THAT THE SYRINGE WAS MISSING SCALE MARKINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577645 SYRINGE 1ML S/T BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other