BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE WITH BD LUER-LOK® TIP 60ML.

    MDR report key: 6745840 · Received July 26, 2017

    Report

    Report Number
    1911916-2017-00042
    Event Type
    Malfunction
    Date Received
    July 26, 2017
    Date of Event
    January 20, 2017
    Report Date
    July 26, 2017
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE EIGHT INCIDENTS EXPIRATION DATES AND LOT NUMBERS LISTED BELOW. EXP: 09/30/2017 - LOT # 2286274 MFG DATE 10/1/2012. EXP. 10/31/2020 - LOT #5290689 MFG DATE 10/1/2015. EXP. 03/31/2021 - LOT # 6102662 MFG DATE 4/1/2016. EXP. 05/31/2021 - LOT # 6132847 MFG DATE 5/1/201. EXP. 07/31/2021 - LOT #6182763 MFG DATE 6/1/2016. EXP. 08/31/2021 - LOT #6217939 MFG DATE 08/01/2016. EXP. 08/31/2021 - LOT #6252586 MFG DATE 09/01/16. ISSUE EIGHT- LOT NUMBER UNKNOWN. MFG DATE UNKNOWN. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS: NO SAMPLES WERE FORWARDED FOR INVESTIGATION. CONCLUSION: WITHOUT A RETURNED SAMPLE, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THIS INCIDENT. UDI# (B)(4).

    Description of Event or Problem · 1

    THERE WAS EIGHT REPORTED INCIDENTS WITH A SYRINGE WITH BD LUER-LOK® TIP 60ML WHERE THE PLUNGER DRIFTS DOWNWARDS WHEN ASPIRATING DRUGS INTO THE SYRINGE. NO MEDICAL INTERVENTIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523533 SYRINGE WITH BD LUER-LOK® TIP 60ML. SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other