BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 ML BD POSIFLUSH¿ STERILE FIELD (SF) SALINE SYRINGE, IN 10 ML SYRINGE

    MDR report key: 7467608 · Received April 26, 2018

    Report

    Report Number
    9616657-2018-00017
    Event Type
    Malfunction
    Date Received
    April 26, 2018
    Date of Event
    April 13, 2018
    Report Date
    June 28, 2018
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    UDI-DI
    30382903065531
    PMA / PMN Number
    K153481
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY NON-CONFORMANCES DURING THE PRODUCTION OF THE TEN PROVIDED LOT NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT OF INFECTION. A THREE YEAR REVIEW OF COMPLAINTS, ENVIRONMENTAL MONITORING RESULTS, WATER TEST RESULTS, AND QUALITY NOTIFICATIONS WAS PERFORMED FOR THE PRODUCT IN QUESTION. UPON REVIEW, THE RECORDS INDICATE THERE WERE NO OCCURRENCES OF SERRATIA MARCESCENS DOCUMENTED WITHIN THE DROGHEDA MANUFACTURING FACILITY. THE DROGHEDA MANUFACTURED POSIFLUSH PRODUCTS ARE STERILIZED USING MOIST HEAT STERILIZATION; A PROCESS WHICH IS ANNUALLY RE-QUALIFIED. THERE IS NO MORPHOLOGICAL EVIDENCE THAT S. MARCESCENS HAS THE ABILITY TO SURVIVE THE MOIST HEAT STERILIZATION PROCESS. IN ADDITION, S. MARCESCENS IS A MOBILE ORGANISM WITH GROWING CONDITIONS OF 5-40 DEGREES CELSIUS, WHICH IS WELL BELOW THE MOIST HEAT STERILIZATION TEMPERATURE OF 121 DEGREES CELSIUS. A CORRECTIVE AND PREVENTIVE ACTION PLAN HAS BEEN INITIATED TO FURTHER INVESTIGATE AND MONITOR THIS ISSUE. SAMPLES UNAVAILABLE, COMPLAINT RAISED IN ASSOCIATION WITH AN FDA INVESTIGATION OF INFECTIONS IN PATIENTS WITH CENTRAL LINES WHOSE TREATMENT INVOLVED THE USE OF POSIFLUSH SP, SF, AND HEPARIN LOCK SYRINGES. CAPA (B)(4) HAS BEEN RAISED TO DEAL WITH THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INFECTIONS ASSOCIATED WITH CENTRAL LINES AND THE USE OF A 10 ML BD POSIFLUSH¿ STERILE FIELD (SF) SALINE SYRINGE, IN 10 ML SYRINGE WERE BEING INVESTIGATED BY THE FDA. THERE WAS NO EVIDENCE THAT THE BD DEVICE IS IMPLICATED BUT ALL SOURCES AND COMMON PRODUCTS ARE BEING INVESTIGATED. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    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 LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7277539. MEDICAL DEVICE EXPIRATION DATE: 9/30/2020. DEVICE MANUFACTURE DATE: 10/4/2017. MEDICAL DEVICE LOT #: 7180928. MEDICAL DEVICE EXPIRATION DATE: 5/31/2020. DEVICE MANUFACTURE DATE: 6/29/2017. MEDICAL DEVICE LOT #: 7244896. MEDICAL DEVICE EXPIRATION DATE: 8/31/2020. DEVICE MANUFACTURE DATE: 9/1/2017. MEDICAL DEVICE LOT #: 7170621. MEDICAL DEVICE EXPIRATION DATE: 5/31/2020. DEVICE MANUFACTURE DATE: 6/19/2017. MEDICAL DEVICE LOT #: 5142042. MEDICAL DEVICE EXPIRATION DATE: 4/30/2018. DEVICE MANUFACTURE DATE: 5/22/2015. MEDICAL DEVICE LOT #: 7089735. MEDICAL DEVICE EXPIRATION DATE: 2/29/2020. DEVICE MANUFACTURE DATE: 3/30/2017. MEDICAL DEVICE LOT #: 6264805. MEDICAL DEVICE EXPIRATION DATE: 8/31/2019. DEVICE MANUFACTURE DATE: 9/20/2016. MEDICAL DEVICE LOT #: 6248559. MEDICAL DEVICE EXPIRATION DATE: 8/31/2018. DEVICE MANUFACTURE DATE: 9/4/2017. MEDICAL DEVICE LOT #: 7130684. MEDICAL DEVICE EXPIRATION DATE: 4/30/2020. DEVICE MANUFACTURE DATE: 5/10/2017. MEDICAL DEVICE LOT #: 6235587. MEDICAL DEVICE EXPIRATION DATE: 7/31/2019. DEVICE MANUFACTURE DATE: 8/22/2016. 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

    CORRECTIONS: EVENT DESCRIPTION: THE STATEMENT, "THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MEDICAL INTERVENTION," SHOULD NOT HAVE BEEN USED IN THE EVENT DESCRIPTION. CORRECTING TO STATE: IT WAS REPORTED THAT INFECTIONS ASSOCIATED WITH CENTRAL LINES AND THE USE OF A 10 ML BD POSIFLUSH¿ STERILE FIELD (SF) SALINE SYRINGE, IN 10 ML SYRINGE WERE BEING INVESTIGATED BY THE FDA. THERE WAS NO EVIDENCE THAT THE BD DEVICE IS IMPLICATED BUT ALL SOURCES AND COMMON PRODUCTS ARE BEING INVESTIGATED. TYPE OF REPORTABLE EVENTS: SHOULD NOT HAVE BEEN LISTED AS "MALFUNCTION". CORRECTING TO INDICATE "SERIOUS INJURY".

    Additional Manufacturer Narrative · 1

    CORRECTION: TYPE OF REPORT: THE INITIAL MDR WAS SUBMITTED AS A 30-DAY REPORT. BD HAS CHANGED OUR POSITION ON THIS INCIDENT AND WE ARE MAKING A CORRECTION TO REPORT THE MDR AS A 5-DAY REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INFECTIONS ASSOCIATED WITH CENTRAL LINES AND THE USE OF A 10 ML BD POSIFLUSH¿ STERILE FIELD (SF) SALINE SYRINGE, IN 10 ML SYRINGE WERE BEING INVESTIGATED BY THE FDA. THERE WAS NO EVIDENCE THAT THE BD DEVICE IS IMPLICATED BUT ALL SOURCES AND COMMON PRODUCTS ARE BEING INVESTIGATED. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INFECTIONS ASSOCIATED WITH CENTRAL LINES AND THE USE OF A 10 ML BD POSIFLUSH¿ STERILE FIELD (SF) SALINE SYRINGE, IN 10 ML SYRINGE WERE BEING INVESTIGATED BY THE FDA. THERE WAS NO EVIDENCE THAT THE BD DEVICE IS IMPLICATED BUT ALL SOURCES AND COMMON PRODUCTS ARE BEING INVESTIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309916 10 ML BD POSIFLUSH¿ STERILE FIELD (SF) SALINE SYRINGE, IN 10 ML SYRINGE PREFILLED SALINE FLUSH SYRINGE NGT BECTON, DICKINSON AND CO. SEE H.10. 30382903065531

    Patients

    Seq Age Sex Outcome Treatment
    1 Other