BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 3 ML SYRINGE

    MDR report key: 7478708 · Received May 1, 2018

    Report

    Report Number
    2134319-2018-00012
    Event Type
    Injury
    Date Received
    May 1, 2018
    Date of Event
    April 24, 2018
    Report Date
    July 18, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FOZ
    UDI-DI
    30382903065074
    PMA / PMN Number
    K011982
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: UPON REVIEW OF ALL 148 POTENTIAL LOT NUMBERS PROVIDED, THERE WERE NO MANUFACTURING RELATED ISSUES NOTED DURING THE PRODUCTION OF THE POTENTIAL LOTS LISTED IN THE COMPLAINT FILE THAT MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. ALL PRODUCT SPECIFICATIONS AND LOT RELEASE ACCEPTANCE CRITERIA FOR THE POTENTIAL LOTS LISTED WERE MET. PRIOR TO THE REPORT OF INFECTION EVALUATED IN MPS-18-1248-SA, THERE WAS NO TREND FOR INFECTION CASES REPORTED FOR FRANKLIN PRODUCT. THIS COMPLAINT IS PART OF A NEW TREND WHICH BEGAN IN APRIL 2018. CAPA 350041 WAS INITIATED TO ADDRESS THIS ISSUE. ALTHOUGH RETAIN SAMPLES ARE AVAILABLE FOR ALL LOTS MANUFACTURED IN FRANKLIN, AS THE LOT NUMBER WAS NOT PROVIDED, RETAIN SAMPLES WERE NOT TESTED. SAMPLES AND/OR PICTURES WERE NOT PROVIDED FOR EVALUATION. A REVIEW OF ALL LOT STERILITY TESTING PERFORMED FOR PRODUCT RELEASED BETWEEN APRIL 2015 & MAY 2018 CONFIRMED THAT NO ORGANISM GROWTH WAS IDENTIFIED FOR ANY LOTS RELEASED DURING THE SHELF-LIFE OF THIS PRODUCT. INVESTIGATION CONCLUSION: THE ROOT CAUSE ANALYSIS OF THE REPORTED INFECTION CASES UNDER CAPA 350041 HAS NOT IDENTIFIED A DIRECT CAUSATION BETWEEN THE INFECTIONS AND THE BD FRANKLIN PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INFANT IN AN NICU TESTED POSITIVE FOR S. MARCESCENS WHILE USING A 3 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 3 ML SYRINGE. IT IS UNKNOWN WHAT SPECIFIC MEDICAL INTERVENTIONS MAY HAVE BEEN PROVIDED. IT WAS ALSO CONFIRMED THAT THE INFANT IS RECOVERING NICELY.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE POTENTIAL LOT NUMBERS WERE PROVIDED FOR THIS INCIDENT. THE INFORMATION FOR EACH POTENTIAL LOT NUMBER IS AS FOLLOWS: LOT #: EXP. DATE: MFG. DATE: 705311B, 2/21/2020, 2/22/2017. 705312B, 2/21/2020, 2/22/2017. 705411B, 2/22/2020, 2/23/2017. 705411C, 2/22/2020, 2/23/2017. 705412B, 2/22/2020, 2/23/2017. 705511B, 2/23/2020, 2/24/2017. 705512B, 2/23/2020, 2/24/2017. 705811B, 2/26/2020, 2/27/2017. 705812B, 2/26/2020, 2/27/2017. 705911B, 2/27/2020, 2/28/2017. 705912B, 2/27/2020, 2/28/2017. 706011B, 2/29/2020, 2/28/2017. 706111B, 3/1/2020, 3/2/2017. 706112B, 3/1/2020, 3/2/2017. 706212B, 3/2/2020, 3/3/2017. 706511B, 3/5/2020, 3/6/2017. 706612B, 3/6/2020, 3/7/2017. 706711B, 3/7/2020, 3/8/2017. 706712B, 3/7/2020, 3/8/2017. 706811B, 3/8/2020, 3/9/2017. 706812B, 3/8/2020, 3/9/2017. 706911B, 3/9/2020, 3/10/2017. 707212B, 3/12/2020, 3/13/2017. 707311B, 3/13/2020, 3/14/2017. 707411B, 3/14/2020, 3/15/2017. 710012C, 4/9/2020, 4/10/2017. 710111C, 4/10/2020, 4/11/2017. 710211C, 4/11/2020, 4/12/2017. 710713C, 4/16/2020, 4/17/2017. 710911C, 4/18/2020, 4/19/2017. 710912C, 4/18/2020, 4/19/2017. 711011C, 4/19/2020, 4/20/2017. 711012C, 4/19/2020, 4/20/2017. 711111C, 4/20/2020, 4/21/2017. 711112C, 4/20/2020, 4/21/2017. 711412C, 4/23/2020, 4/24/2017. 711511C, 4/24/2020, 4/25/2017. 711512C, 4/24/2020, 4/25/2017. 711612C, 4/25/2020, 4/26/2017. 711711C, 4/26/2020, 4/27/2017. 711712C, 4/26/2020, 4/27/2017. 711811C, 4/27/2020, 4/28/2017. 713111C, 5/10/2020, 5/11/2017. 713212C, 5/11/2020, 5/12/2017. 713512C, 5/14/2020, 5/15/2017. 713612C, 5/15/2020, 5/16/2017. 713711C, 5/16/2020, 5/17/2017. 713811C, 5/17/2020, 5/18/2017. 713912C, 5/18/2020, 5/19/2017. 714211C, 5/21/2020, 5/22/2017. 714311C, 5/22/2020, 5/23/2017. 715012C, 5/29/2020, 5/30/2017. 715211C, 5/31/2020, 6/1/2017. 715311C, 6/1/2020, 6/2/2017. 715611B, 6/4/2020, 6/5/2017. 715711B, 6/5/2020, 6/6/2017. 715811B, 6/6/2020, 6/7/2017. 715911B, 6/7/2020, 6/8/2017. 716011B, 6/8/2020, 6/9/2017. 716111B, 6/9/2020, 6/10/2017. 716311B, 6/11/2020, 6/12/2017. 716411B, 6/12/2020, 6/13/2017. 718811C, 7/6/2020, 7/7/2017. 719111C, 7/9/2020, 7/10/2017. 719211C, 7/10/2020, 7/11/2017. 719311C, 7/11/2020, 7/12/2017. 719411C, 7/12/2020, 7/13/2017. 719511C, 7/13/2020, 7/14/2017. 719812C, 7/16/2020, 7/17/2017. 719912C, 7/17/2020, 7/18/2017. 720011C, 7/18/2020, 7/19/2017. 720111C, 7/19/2020, 7/20/2017. 720211C, 7/20/2020, 7/21/2017. 720511C, 7/23/2020, 7/24/2017. 722612B, 8/13/2020, 8/14/2017. 722711B, 8/14/2020, 8/15/2017. 722811B, 8/15/2020, 8/16/2017. 722911B, 8/16/2020, 8/17/2017. 723011B, 8/17/2020, 8/18/2017. 723311B, 8/20/2020, 8/21/2017. 723512B, 8/22/2020, 8/23/2017. 723611B, 8/23/2020, 8/24/2017. 723612B, 8/23/2020, 8/24/2017. 723711B, 8/24/2020, 8/25/2017. 723712B, 8/24/2020, 8/25/2017. 723811B, 8/25/2020, 8/26/2017. 723812B, 8/25/2020, 8/26/2017. 724011B, 8/27/2020, 8/28/2017. 724012B, 8/27/2020, 8/28/2017. 724111B, 8/28/2020, 8/29/2017. 724112B, 8/28/2020, 8/29/2017. 724211B, 8/29/2020, 8/30/2017. 724212B, 8/29/2020, 8/30/2017. 724311B, 8/30/2020, 8/31/2017. 724312B, 8/30/2020, 8/31/2017. 724411B, 8/31/2020, 9/1/2017. 724812B, 9/4/2020, 9/5/2017. 724911B, 9/5/2020, 9/6/2017. 725011B, 9/6/2020, 9/7/2017. 725111B, 9/7/2020, 9/8/2017. 725211B, 9/8/2020, 9/9/2017. 725411B, 9/10/2020, 9/11/2017. 725611C, 9/12/2020, 9/13/2017. 725711C, 9/13/2020, 9/14/2017. 725811C, 9/14/2020, 9/15/2017. 728512C, 10/11/2020, 10/12/2017. 728611C, 10/12/2020, 10/13/2017. 729012C, 10/16/2020, 10/17/2017. 729111C, 10/17/2020, 10/18/2017. 729211C, 10/18/2020, 10/19/2017. 729311C, 10/19/2020, 10/20/2017. 729711C, 10/23/2020, 10/24/2017. 729712C, 10/23/2020, 10/24/2017. 729811C, 10/24/2020, 10/25/2017. 729812C, 10/24/2020, 10/25/2017. 729911C, 10/25/2020, 10/26/2017. 729912C, 10/25/2020, 10/26/2017. 730011C, 10/26/2020, 10/27/2017. 730012C, 10/26/2020, 10/27/2017. 730111C, 10/27/2020, 10/28/2017. 731011C, 11/5/2020, 11/6/2017. 731012C, 11/5/2020, 11/6/2017. 731112C, 11/6/2020, 11/7/2017. 731211C, 11/7/2020, 11/8/2017. 731212C, 11/7/2020, 11/8/2017. 731311C, 11/8/2020, 11/9/2017. 731312C, 11/8/2020, 11/9/2017. 731411C, 11/9/2020, 11/10/2017. 731712C, 11/12/2020, 11/13/2017. 731812C, 11/13/2020, 11/14/2017. 731911C, 11/14/2020, 11/15/2017. 732011C, 11/15/2020, 11/16/2017. 732111C, 11/16/2020, 11/17/2017. 732411C, 11/19/2020, 11/20/2017. 732511C, 11/20/2020, 11/21/2017. 733511C, 11/30/2020, 12/1/2017. 733811C, 12/3/2020, 12/4/2017. 733911C, 12/4/2020, 12/5/2017. 734011C, 12/5/2020, 12/6/2017. 734012C, 12/5/2020, 12/6/2017. 734111C, 12/6/2020, 12/7/2017. 734512C, 12/10/2020, 12/11/2017. 734611C, 12/11/2020, 12/12/2017. 734711C, 12/12/2020, 12/13/2017. 734811C, 12/13/2020, 12/14/2017. 734911C, 12/14/2020, 12/15/2017. 735011C, 12/15/2020, 12/15/2017. 735211C, 12/17/2020, 12/15/2017. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFANT IN AN NICU TESTED POSITIVE FOR S. MARCESCENS WHILE USING A 3 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 3 ML SYRINGE. IT IS UNKNOWN WHAT SPECIFIC MEDICAL INTERVENTIONS MAY HAVE BEEN PROVIDED. IT WAS ALSO CONFIRMED THAT THE INFANT IS RECOVERING NICELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318237 3 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 3 ML SYRINGE PREFILLED SALINE FLUSH SYRINGE FOZ BECTON DICKINSON MEDICAL SYSTEMS SEE H.10. 30382903065074

    Patients

    Seq Age Sex Outcome Treatment
    1 Other