BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6MM BD¿ INSULIN SYRINGE

    MDR report key: 6946058 · Received October 12, 2017

    Report

    Report Number
    1920898-2017-00238
    Event Type
    Malfunction
    Date Received
    October 12, 2017
    Date of Event
    September 18, 2017
    Report Date
    December 5, 2017
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED FROM LOT # 7023681 AND 7100843. ADDITIONAL LOT NUMBER RECEIVED: MEDICAL DEVICE LOT #: 7100843, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: 04/10/2017. RESULTS - CUSTOMER RETURNED (20) 3/10CC, 6MM, 31G SYRINGES IN SEALED POLY BAGS FROM LOT # 7023681 AND (22) 3/10CC, 6MM, 31G SYRINGES (12 IN OPEN POLY BAGS, 10 IN A SEALED POLY BAGS) FROM LOT # 7100843. CUSTOMER STATES THAT THE SCALE MARKINGS ARE OFF. ALL RETURNED SYRINGES WERE TESTED USING THE PLUG GAUGE AND ALL SCALE MARKINGS FALL WITHIN SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 7023681 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. DURING PRODUCTION OF THE ABOVE LISTED BATCHES, THERE WERE THREE (3) NOTIFICATIONS INITIATED FOR RELATED DEFECTS FOUND DURING IN-LINE INSPECTIONS: QN# (B)(4). ALL AFFECTED PRODUCT ASSOCIATED WITH THE ABOVE NOTIFICATIONS AND VERIFIED TO BE REJECTABLE WAS DISPOSITIONED PRIOR TO CLOSURE OF THE NOTIFICATIONS. ALSO, A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 7100843 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS [(B)(4)] FOR UNRELATED ISSUES NOTED DURING REVIEW OF DOCUMENTATION FROM PRODUCTION OF THE ABOVE LISTED BATCHES CONCLUSION - UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER. WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 6 MM BD¿ INSULIN SYRINGE HAD INCORRECT SCALE MARKINGS. THIS WAS NOTICED BEFORE USE AND THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722854 6MM BD¿ INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 7023681

    Patients

    Seq Age Sex Outcome Treatment
    1 Other