BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE

    MDR report key: 11566463 · Received March 24, 2021

    Report

    Report Number
    1920898-2021-00345
    Event Type
    Malfunction
    Date Received
    March 24, 2021
    Date of Event
    February 26, 2021
    Report Date
    March 21, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. TWO PHOTOS OF SYRINGES IN A POLYBAG FROM LOT# 0062085 WERE PROVIDED. THE CUSTOMER REPORTED THAT SHE COULD OBSERVE UNITS WITHOUT THE VACUUM. THE PHOTOS WERE EXAMINED, AND NO ISSUES WERE OBSERVED ON THE SYRINGES INSIDE THE POLYBAG. SINCE NO DEFECTS WERE OBSERVED THE ALLEGED ISSUE COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0062085. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200880116] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. AS NO SAMPLES WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE BASED ON THE PHOTOS RECEIVED ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA/SA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE PLUNGER WAS LOOSE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "CUSTOMER PURCHASED 2 PACKAGES OF SYRINGES AND EVEN WITHOUT OPENING THEM SHE COULD OBSERVE UNITS WITHOUT THE VACUUM"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456407 BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0062085

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR