BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE

    MDR report key: 8689092 · Received June 11, 2019

    Report

    Report Number
    1920898-2019-00526
    Event Type
    Malfunction
    Date Received
    June 11, 2019
    Date of Event
    May 20, 2019
    Report Date
    July 3, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249091
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 5180840 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    MATERIAL NO. 324909 BATCH NO. 5180840. IT WAS REPORTED THAT DURING USE OF THE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE A TRANSLUCENT LIQUID IS INSIDE OF BARREL OF SYRINGE PRIOR TO INJECTION. WHEN SHE INJECTED, IT STUNG GOING INTO SITE. SHE MENTIONED ISSUE TO ENDOCRINOLOGIST BUT HE DID NOT SEEM CONCERNED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING LIQUID INSIDE BARREL OF SYRINGE PRIOR TO INJECTION. DESCRIBED IT AS "TRANSLUCENT". STATED SOME OF THE LIQUID WENT INTO HER VIAL AND WHEN SHE INJECTED, IT STUNG GOING IN TO SITE. STATED SHE DID MENTION IT TO HER ENDOCRINOLOGIST BUT HE DID NOT SEEM CONCERNED. SENDING IN UN-USED SAMPLES. LOT: 5180840, ITEM: 324909. OCCURRENCE DATE UNKNOWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EVALUATED BY MFR: 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. 324909, BATCH NO. 5180840. IT WAS REPORTED THAT DURING USE OF THE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE A TRANSLUCENT LIQUID IS INSIDE OF BARREL OF SYRINGE PRIOR TO INJECTION. WHEN SHE INJECTED, IT STUNG GOING INTO SITE. SHE MENTIONED ISSUE TO ENDOCRINOLOGIST BUT HE DID NOT SEEM CONCERNED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING LIQUID INSIDE BARREL OF SYRINGE PRIOR TO INJECTION. DESCRIBED IT AS "TRANSLUCENT". STATED SOME OF THE LIQUID WENT INTO HER VIAL AND WHEN SHE INJECTED, IT STUNG GOING IN TO SITE. STATED SHE DID MENTION IT TO HER ENDOCRINOLOGIST BUT HE DID NOT SEEM CONCERNED. SENDING IN UN-USED SAMPLES. LOT: 5180840, ITEM: 324909. OCCURRENCE DATE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479625 BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 5180840 00382903249091

    Patients

    Seq Age Sex Outcome Treatment
    1 Other