BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER

    MDR report key: 7087207 · Received December 6, 2017

    Report

    Report Number
    1024879-2017-01212
    Event Type
    Malfunction
    Date Received
    December 6, 2017
    Date of Event
    April 6, 2017
    Report Date
    February 14, 2018
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686075
    PMA / PMN Number
    K982541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7027638 MEDICAL DEVICE EXPIRATION DATE: 1/31/2022 DEVICE MANUFACTURE DATE: 1/27/2017 MEDICAL DEVICE LOT #: 7012544 MEDICAL DEVICE EXPIRATION DATE: 1/31/2022 DEVICE MANUFACTURE DATE: 1/12/2017 MEDICAL DEVICE LOT #: 7019587 MEDICAL DEVICE EXPIRATION DATE: 1/31/2022 DEVICE MANUFACTURE DATE: 1/19/2017 RESULTS: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES AND PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR SLEEVE NON-RECOVERY AND BLOOD LEAKAGE WITH THE INCIDENT LOT WAS OBSERVED. BD HAS INITIATED A CAPA TO DOCUMENT FURTHER INVESTIGATION AND ROOT CAUSE(S) OF THIS PRODUCT ISSUE. CONCLUSION: CAPA (B)(4) HAS BEEN OPENED.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS SUBMITTED WITH THE INCORRECT MEDICAL DEVICE TYPE. THE CORRECT TYPE IS FMI.

    Additional Manufacturer Narrative · 1

    CORRECTION: THE INITIAL MDR WAS SUBMITTED WITH THE DATE OF EVENT LISTED AS UNKNOWN AND THE AWARENESS DATE WAS USED IN THAT FIELD. THE PRODUCT INCIDENT REPORT SHOWS THE DATE OF EVENT WAS (B)(6) 2017. CORRECTION: THE INITIAL MDR WAS SUBMITTED WITH THE DATE OF AWARENESS LISTED AS 04/11/2017. THE PRODUCT INCIDENT REPORT SHOWS THE DATE OF AWARENESS WAS 04/07/2017.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RUBBER SLEEVE OF BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER STAYED UP LEAVING NEEDLE UNPROTECTED LEADING TO BLOOD LEAKAGE. NO BLOOD EXPOSURE TO MUCOUS MEMBRANE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867503 BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER BLOOD COLLECTION SET FMI BECTON, DICKINSON & CO., (BD) SEE H.10 50382903686075

    Patients

    Seq Age Sex Outcome Treatment
    1 Other