BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE

    MDR report key: 10114692 · Received June 3, 2020

    Report

    Report Number
    1920898-2020-00620
    Event Type
    Malfunction
    Date Received
    June 3, 2020
    Date of Event
    May 13, 2020
    Report Date
    June 18, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908438032
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 6/8/2020. H.6. INVESTIGATION: CUSTOMER RETURNED THREE (3) 31GX8MM, 0.3ML BD INSULIN SYRINGES FROM AN OPEN POLYBAG FROM LOT 9161986. CONSUMER REPORTED THAT NEEDLE WAS BLOCKED AND WOULD DRAW INSULIN. ALL THREE RETURNED SYRINGES WERE EXAMINED, THEN TESTED FOR FLOW: TWO OUT OF THE THREE RETURNED SYRINGES WERE ABLE TO DRAW AND EXPEL PROPERLY. A WIRE TEST WAS PERFORMED ON THE ONE SYRINGE THAT COULD NOT DRAW PROPERLY: THE WIRE WAS ABLE TO PASS THROUGH THE LENGTH OF THE CANNULA; NO EVIDENCE OF A CLEARED BLOCKAGE OR RESIDUE WAS OBSERVED AFTER PERFORMING THE WIRE TEST. THIS SYRINGE WAS TESTED FOR FLOW AFTER PERFORMING THE WIRE TEST: THE SYRINGE WAS ABLE TO DRAW AND EXPEL PROPERLY. A CLOG WITHIN THE SYRINGE CANNULA WOULD HAVE RESULTED IN THE SYRINGE NOT BEING ABLE TO DRAW PROPERLY (AS REPORTED), HOWEVER, THE CAUSE FOR THE CLOGGED CANNULA COULD NOT BE DETERMINED BECAUSE NO EVIDENCE OF THE MATERIAL BLOCKING THE CANNULA WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9161986. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED FOR INSUFFICIENT LUBE. THERE WERE TWO (2) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. - CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (CLOG) - UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (NEEDLE POINT INTEGRITY - NO HOLE) THE ROOT CAUSE FOR THIS ISSUE (CLOGGED CANNULA) COULD NOT BE DETERMINED BECAUSE NO EVIDENCE OF A CLEARED BLOCKAGE OR RESIDUE WAS OBSERVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE BLOCKAGE OF NEEDLE OCCURRED AND WAS UNABLE TO DELIVER INSULIN WITH A BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2 COMPLAINTS) CONSUMER STATED THAT NEEDLE WAS BLOCKED AND WOULD DRAW INSULIN.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE BLOCKAGE OF NEEDLE OCCURRED AND WAS UNABLE TO DELIVER INSULIN WITH A BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2 COMPLAINTS) CONSUMER STATED THAT NEEDLE WAS BLOCKED AND WOULD DRAW INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580887 BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328438 9161986 00382908438032

    Patients

    Seq Age Sex Outcome Treatment
    1 Other