BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER

    MDR report key: 7064568 · Received November 28, 2017

    Report

    Report Number
    1024879-2017-00852
    Event Type
    Malfunction
    Date Received
    November 28, 2017
    Date of Event
    August 9, 2016
    Report Date
    October 27, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    00382903672905
    PMA / PMN Number
    K991088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT #6041664, EXP DATE 02-28-2019, MANUFACTURING DATE: 02/10/2016. LOT #6127588, EXP DATE 04-30-2019, MANUFACTURING DATE: 05/06/2016. LOT #6140965, EXP DATE 05-31-2019, MANUFACTURING DATE: 05/19/2016. LOT #6161614, EXP DATE 05-31-2019 MANUFACTURING DATE: 06/09/2016 SIX CUSTOMER SAMPLES WERE RECEIVED FROM BATCH 6161461. SLEEVE DISCOLORATION WAS CONFIRMED ON ALL SIX SAMPLES. HOWEVER, NO CUSTOMER SAMPLES FROM LOT 6041664 WERE RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE ACCOMPANYING LOT # 6041664, 6127588, 6140965, AND 6161614. CONCLUSION: FOR CONFIRMED COMPLAINTS FROM LOT #6161461 AND POTENTIAL COMPLAINTS FROM RECORDED LOT #6041664: ROOT CAUSE- MICA NOT DISPERSED PROPERLY OR NOT ENOUGH MICA. MICA ALLOWS THE LASER TO WRITE ON THE PLASTIC ABSORBING THE LASER. BASED ON AN EVALUATION OF SEVERITY AND FREQUENCY, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USING THE BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER, THE USER NOTED SEVERAL LUER ADAPTERS HAD A DISCOLORATION ROUND THE RUBBER SLEEVE. IT APPEARS TO BE A RUST COLORED DISCOLORATION ON THE SLEEVE OF THE NEEDLE CANNULA WITH A SLIGHTLY RAISED, ROUGH APPEARANCE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841740 BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER TUBE ADAPTERS AND HOLDERS JKA BECTON, DICKINSON & CO., (BD) 6041664 00382903672905

    Patients

    Seq Age Sex Outcome Treatment
    1 Other