BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH BD ULTRA-FINE NEEDLE

    MDR report key: 11159606 · Received January 13, 2021

    Report

    Report Number
    1920898-2021-00037
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    December 16, 2020
    Report Date
    February 16, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K170386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (5) LOOSE 31GX8MM, 1ML BD INSULIN SYRINGES. CONSUMER REPORTED HAVING SEVERAL SYRINGES WITH NO DEAD SPACE; STATED THE SYRINGES LOOK AS IF THEY HAVE BEEN USED. ALL 5 RETURNED SYRINGES WERE EXAMINED, AND NONE EXHIBITED ISSUES REGARDING THE OVERALL SYRINGE ASSEMBLY OR PLACEMENT OF THE PLUNGER ROD; NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED; NO DAMAGE WAS OBSERVED ON THE SYRINGES. SINCE NO DEFECT WAS OBSERVED THE ALLEGED ISSUE COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8190613. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE SEVEN (7) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PLUNGER WAS INCORRECTLY PLACED IN SYRINGE WITH BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SEVERAL SYRINGES HAD NO DEAD SPACE AND LOOKED AS IF THEY HAD BEEN USED. ALSO, THIS HAPPENED WITH PREVIOUS BOX.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8190613. MEDICAL DEVICE EXPIRATION DATE: 2023-07-31. DEVICE MANUFACTURE DATE: 2018-07-09. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLUNGER WAS INCORRECTLY PLACED IN SYRINGE WITH BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SEVERAL SYRINGES HAD NO DEAD SPACE AND LOOKED AS IF THEY HAD BEEN USED. ALSO, THIS HAPPENED WITH PREVIOUS BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56526 BD INSULIN SYRINGES WITH BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1