BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 1ML SYRINGE LUER-LOK¿ TIP

    MDR report key: 9520280 · Received December 26, 2019

    Report

    Report Number
    1911916-2019-01326
    Event Type
    Malfunction
    Date Received
    December 26, 2019
    Date of Event
    December 6, 2019
    Report Date
    January 9, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    KYZ
    UDI-DI
    30382903096207
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES OR PHOTOS WERE RECEIVED; THEREFORE, SAMPLE ANALYSIS COULD NOT BE PERFORMED AND THE CONDITIONS REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD 1ML SYRINGE LUER-LOK¿ TIP LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309620 BATCH NO.: 9240843 IT WAS REPORTED THAT A UNIT THAT USES THESE SYRINGES FOR FILLING FEEDING TUBES WERE EXPERIENCING LEAKAGE FROM THE SEAL AT THE BOTTOM AND FROM THE TIP. PER EMAIL: A UNIT THAT USES THESE FOR FILLING FEEDING TUBES SHOWED ME TODAY THAT THEY ARE LEAKING FROM THE TIP AND THE SEAL AT THE BOTTOM OF THE SYRINGE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD 1ML SYRINGE LUER-LOK¿ TIP LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309620 BATCH NO.: 9240843. IT WAS REPORTED THAT A UNIT THAT USES THESE SYRINGES FOR FILLING FEEDING TUBES WERE EXPERIENCING LEAKAGE FROM THE SEAL AT THE BOTTOM AND FROM THE TIP. PER EMAIL: A UNIT THAT USES THESE FOR FILLING FEEDING TUBES SHOWED ME TODAY THAT THEY ARE LEAKING FROM THE TIP AND THE SEAL AT THE BOTTOM OF THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1316977 BD 1ML SYRINGE LUER-LOK¿ TIP IRRIGATING SYRINGE KYZ BD MEDICAL (BD WEST) MEDICAL SURGICAL 309620 9240843 30382903096207

    Patients

    Seq Age Sex Outcome Treatment
    1 Other