BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 ML BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 10448161 · Received August 25, 2020

    Report

    Report Number
    9610847-2020-00258
    Event Type
    Malfunction
    Date Received
    August 25, 2020
    Date of Event
    August 3, 2020
    Report Date
    September 30, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903059080
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: 8/26/2020. H.6. INVESTIGATION: CUSTOMER RETURNED (1) 10 ML, 40MM, 22G BD SAFETYGLIDE SYRINGE WITH AN OPENED BLISTER PACK FROM LOT # 9031536. CUSTOMER STATES THAT THE NEEDLE IS BROKEN. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A BENT CANNULA. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED THAT BD WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED FAILURE. ROOT CAUSE: BENT DURING USE OF THE PRODUCT BY THE CUSTOMER. A REVIEW OF THE BATCH HISTORY RECORD FOR THE COMPLAINT LOT WAS SATISFACTORY AND THERE WERE NO RELATED QUALITY NOTIFICATIONS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE WAS DISCOVERED TO BE BROKEN PRIOR TO USE WITH A 1 ML BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BROKEN NEEDLE.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: MEDICAL DEVICE TYPE: FMI, COMMON DEVICE NAME: HYPODERMIC SINGLE LUMEN NEEDLE, PMA / 510(K)#: K951254. 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 NEEDLE WAS DISCOVERED TO BE BROKEN PRIOR TO USE WITH A 1 ML BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BROKEN NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916562 1 ML BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 305908 9031536 30382903059080

    Patients

    Seq Age Sex Outcome Treatment
    1 Other