BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VEO INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 9203137 · Received October 17, 2019

    Report

    Report Number
    1920898-2019-01160
    Event Type
    Malfunction
    Date Received
    October 17, 2019
    Date of Event
    October 3, 2019
    Report Date
    October 28, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249114
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER RETURNED (1) LOOSE 3/10CC, 6MM SYRINGE. CUSTOMER STATES THAT THE SHIELD WAS MISSING. THE SYRINGE WAS RETURNED WITHOUT THE SHIELD AND WITHOUT ANY PACKAGING. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 3190223. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS A MANUFACTURING ISSUE AS THE SAMPLE WAS RETURNED LOOSE WITHOUT ANY PACKAGING ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    MATERIAL NO. 324911 BATCH NO. 3190223. IT WAS REPORTED THAT BEFORE USE OF THE BD VEO¿ INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE THE NEEDLE SHIELD WAS MISSING FROM SYRINGE AND WAS NOT IN POLYBAG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FIND SHIELD MISSING FROM 1 SYRINGE NOT LOOSE IN BAG, COMPLETELY MISSING. THE BAG WAS SEALED HE DID NOT STICK HIMSELF.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: N/A. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO. 324911 BATCH NO. 3190223. IT WAS REPORTED THAT BEFORE USE OF THE BD VEO¿ INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE THE NEEDLE SHIELD WAS MISSING FROM SYRINGE AND WAS NOT IN POLYBAG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FIND SHIELD MISSING FROM 1 SYRINGE NOT LOOSE IN BAG, COMPLETELY MISSING. THE BAG WAS SEALED HE DID NOT STICK HIMSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999997 BD VEO INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 3190223 00382903249114

    Patients

    Seq Age Sex Outcome Treatment
    1 Other