BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    23 G X .75 IN BD VACUTAINER® WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 6183256 · Received December 16, 2016

    Report

    Report Number
    1024879-2016-00073
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    November 7, 2016
    Report Date
    February 3, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: ON 1/10/2017, TWENTY SAMPLES FROM CAT # 367342, LOT # 6180542 WERE RETURNED FOR EVALUATION. ALL TWENTY CUSTOMER SAMPLES WERE EVALUATED FOR IV NEEDLE RETRACTION AND LOCKOUT. THE IV NEEDLE OF ALL TWENTY SAMPLES RETRACTED AND REMAINED LOCKED OUT WITHOUT INCIDENT. CONCLUSION: BD WAS NOT ABLE TO DUPLICATE THE CUSTOMER'S INDICATED FAILURE MODE DURING SAMPLE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ON 12/19/2016 THE CUSTOMER PROVIDED CORRECTED INFORMATION FOR THE SECOND LOT # THAT WAS REPORTED IN ERROR. THE INFORMATION FOR THIS LOT # IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6180542; MEDICAL DEVICE EXPIRATION DATE: 6/30/2018; DEVICE MANUFACTURE DATE: 6/28/2016. DEVICE EVALUATION: A SAMPLE WAS NOT RETURNED FOR EVALUATION. (B)(4) HAS BEEN INITIATED FOR NEEDLE RETRACTION FAILURE TO DOCUMENT THE INVESTIGATION PATH, ROOT CAUSE ANALYSIS, AND REMEDIATION PLAN TO INCLUDE CORRECTIVE AND PREVENTIVE ACTIONS. AS THIS IS A CONFIRMED COMPLAINT, A DHR REVIEW IS NOT REQUIRED. CONCLUSION: PER (B)(4) THIS IS A CONFIRMED COMPLAINT RELATED TO CHANGE OF RESIN TO ABS AND CRACKED CORE PINS.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: THE INITIAL REPORTER ALSO PROVIDED A SECOND LOT NUMBER; 6080542, FOR THIS INCIDENT. HOWEVER, LOT NUMBER 6080542 IS NOT VALID FOR THE REPORTED CATALOG NUMBER. THE INITIAL REPORTER HAS BEEN CONTACTED FOR CLARIFICATION, BUT A RESPONSE HAS NOT YET BEEN RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE UPDATED WHEN THE SUPPLEMENTAL MDR IS FILED. 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 THERE WERE TWO OCCURRENCES WHERE A 23 G X .75 IN BD VACUTAINER® WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET WITH 12 IN TUBING AND LUER ADAPTER DID NOT RETRACT WHEN THE SAFETY MECHANISM WAS ACTIVATED. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833455 23 G X .75 IN BD VACUTAINER® WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET BLOOD COLLECTION SET JKA BECTON, DICKINSON & CO., (BD) 6180564

    Patients

    Seq Age Sex Outcome Treatment
    1 Other