BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    18 G X 1 1/2 IN. BD¿ BLUNT FILTER NEEDLE

    MDR report key: 7059215 · Received November 27, 2017

    Report

    Report Number
    1911916-2017-00320
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    July 26, 2017
    Report Date
    March 1, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    GAA
    UDI-DI
    00382903052110
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: NO PHOTOS OR SAMPLES WERE RECEIVED IN THE COLUMBUS PLANT FOR EVALUATION THEREFORE FAILURE MODE COULD NOT BE VERIFIED AND ROOT CAUSE COULD NOT BE DETERMINED. POSSIBLE ROOT CAUSE: PARTS SEPARATION DURING THE PACKAGING OPERATION. OPERATOR ERROR. A SECOND OPERATOR MONITORS THE PACKAGING LINE TO REMOVE UNSHIELDED NEEDLES, FILL EMPTY BLISTERS, AND REMOVE HIGH PARTS. THE PACKAGE WILL HAVE LITTLE HOLES CAUSED BY THE END OF THE UNSHIELDED NEEDLE. DHR REVIEW SHOWS BATCH 5239925 HAD NINE VISUAL INSPECTIONS PERFORMED ON 630 PARTS WITH ZERO DEFECTS NOTED. ASSEMBLY BATCH 5240592 HAD 136 VISUAL INSPECTIONS PERFORMED ON 6,950 PARTS WITH ZERO DEFECTS NOTED. SHIELD REMOVAL FORCE TESTING WAS PERFORMED 68 TIMES USING 340 PARTS WITH A MINIMUM REMOVAL FORCE OF 2.7 LBS., A MAXIMUM REMOVAL FORCE OF 8.19 LBS., AND AN AVERAGE OF 4.61 LBS. THE SPECIFICATION LIMITS FOR SHIELD REMOVAL FORCES ARE 0.5 ¿ 12.0 LBS. WITH AN AVERAGE < 9.0 LBS. NO NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCH. QN REVIEW: NO NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCH. IF CORRECTIVE/PREVENTATIVE ACTION NOT REQUIRED, PROVIDE RATIONALE: THE OPERATOR INSTRUCTION HAS BEEN UPDATED TO REFLECT THE REQUIREMENT OF A SECOND OPERATOR, AND DEFINE WHAT THEY ARE MONITORING THE PARTS FOR. THE MONITORING OPERATORS HAVE ALSO BEEN ADVISED TO MORE DILIGENT WHEN THE MACHINE STOPS TO VERIFY AND CORRECT THE REASON FOR THE STOPPAGE PRIOR TO RESTARTING THE LINE.

    Description of Event or Problem · 1

    IT WAS REPORTED BEFORE USE THAT THE 18 G X 1 1/2 IN. BD¿ BLUNT FILTER NEEDLE HAD DEFECTIVE OR DAMAGED PACKAGING. NO REPORTS OR INJURY OR MEDICAL INTERVENTION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838907 18 G X 1 1/2 IN. BD¿ BLUNT FILTER NEEDLE BLUNT/FILTER NEEDLE GAA BECTON DICKINSON 5239925 00382903052110

    Patients

    Seq Age Sex Outcome Treatment
    1 Other