BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 ML BD POSIFLUSH¿ SF SALINE SYRINGE

    MDR report key: 7332288 · Received March 12, 2018

    Report

    Report Number
    9616657-2018-00008
    Event Type
    Malfunction
    Date Received
    March 12, 2018
    Date of Event
    February 16, 2018
    Report Date
    April 17, 2018
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    UDI-DI
    30382903065531
    PMA / PMN Number
    K153481
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A NO SAMPLE INVESTIGATION WAS COMPLETED BY OUR QUALITY ENGINEER TEAM. UPON REVIEW OF THE REPORTED INFORMATION, THE DISCOLORATION OF THE SYRINGE PACKAGING WAS CONFIRMED FOR ALL OF THE PROVIDED LOT NUMBERS. THE STAINS OCCUR AS A RESULT THE INTERACTION BETWEEN THE PAPER AND THE MOIST HEAT STERILIZATION PROCESS. TEST RESULTS HAVE CONFIRMED THE STAINS ARE COSMETIC ONLY IN NATURE AND DO NOT PERMEATE THROUGH THE PACKAGING TO THE PRODUCT. MICROBIAL PERMEABILITY TESTING, CYTOTOXICITY TESTING, AND TESTING FOR RESIDUAL SOLVENTS AND VOLATILE SPECIES HAS BEEN COMPLETED ON THE PACKAGES DISPLAYING THE BROWNISH STAIN. THE TESTING CONFIRMED THAT THEY DO NOT PRESENT ANY RISK TO THE USE OF THE PRODUCT AND HAVE NO IMPACT ON THE EFFECTIVENESS, STERILITY, QUALITY, OR SAFETY OF BD POSIFLUSH SF 10ML SALINE FLUSH SYRINGE. A REVIEW OF THE PRODUCTION HISTORY SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES FOR ANY OF THE PROVIDED LOT NUMBERS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT. SYRINGE DISCOLORATION, LOTS 6264805, 7130684, 7170621, 7244896 7277539, & 7319531 NO SAMPLE RECEIVED. DHR 6264805: THERE WERE NO NON-CONFORMANCES RELATING TO THIS DEFECT. DHR 7319531: THERE WERE NO NON-CONFORMANCES RELATING TO THIS DEFECT. DHR 7277539: THERE WERE NO NON-CONFORMANCES RELATING TO THIS DEFECT. DHR 7244896: THERE WERE NO NON-CONFORMANCES RELATING TO THIS DEFECT. DHR 7170621: THERE WERE NO NON-CONFORMANCES RELATING TO THIS DEFECT. DHR 7130684: THERE WERE NO NON-CONFORMANCES RELATING TO THIS DEFECT. RISK ASSESSMENT: IN 2017, FOR THIS DEFECT TYPE, COMPLAINTS WERE REPORTED AT AN AVERAGE OF 3 PER MONTH. OCCURRENCE RATE VARIES BETWEEN CUSTOMERS, BUT A TOTAL OF 26 HAVE BEEN RECORDED FOR THIS SPECIFIC DEFECT FROM JANUARY TO AUGUST 2017. CORRECTIVE ACTION: REQUIRED. CAPA (B)(4) HAS BEEN RAISED FOLLOWING UNIT LEVEL DISCUSSIONS IN SEPTEMBER 2017. EXCEPTIONS: LOT NUMBERS MANUFACTURED PRIOR TO LOT 6315951 MAY HAVE ASSOCIATED STAINING COMPLAINTS AS A RESULT OF STERILIZER COMPONENT ISSUES. THIS WAS ADDRESSED IN CAPA (B)(4) AND THE ASSOCIATED CORRECTIVE ACTION WAS IMPLEMENTED NOVEMBER 2016. LOT NUMBER 6315951 WAS THE FIRST LOT NUMBER MANUFACTURED POST CORRECTIVE ACTION IMPLEMENTATION. LOT NUMBERS PRIOR TO LOT 6315951 MAY GENERATE CUSTOMER COMPLAINTS FOR STAINING, THESE COMPLAINTS ARE NOT WITHIN SCOPE OF THIS PIC AND SHALL BE ADDRESSED ON AN INDIVIDUAL BASIS. A CORRECTIVE ACTION PLAN HAS BEEN IMPLEMENTED TO REDUCE THE PRESENCE OF THE BROWN PACKAGING STAINS. AS NO SAMPLES WERE RECEIVED, BD WAS UNABLE TO CONFIRM THE DEFECT OF SYRINGE DISCOLORATION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. SIX POTENTIAL LOT NUMBERS WERE PROVIDED FOR THIS INCIDENT. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6264805, MEDICAL DEVICE EXPIRATION DATE: 08/31/2019, DEVICE MANUFACTURE DATE: 09/20/2016. MEDICAL DEVICE LOT #: 7130684, MEDICAL DEVICE EXPIRATION DATE: 2020, DEVICE MANUFACTURE DATE: 05/10/2017. MEDICAL DEVICE LOT #: 7170621, MEDICAL DEVICE EXPIRATION DATE: 05/31/2020, DEVICE MANUFACTURE DATE: 06/19/2017. MEDICAL DEVICE LOT #: 7244896, MEDICAL DEVICE EXPIRATION DATE:08/31/ 2020, DEVICE MANUFACTURE DATE: 09/01/2017. MEDICAL DEVICE LOT #: 7277539, MEDICAL DEVICE EXPIRATION DATE: 09/30/2020, DEVICE MANUFACTURE DATE: 10/04/2017. MEDICAL DEVICE LOT #: 7319531, MEDICAL DEVICE EXPIRATION DATE: 10/31/2020, DEVICE MANUFACTURE DATE: 11/15/2017. 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 THE PACKAGING ON A 10 ML BD POSIFLUSH¿ SF SALINE SYRINGE WAS FOUND WITH A ¿YELLOW¿ DISCOLORING AND LOOKED AND FELT LIKE IT WAS WET. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176013 10 ML BD POSIFLUSH¿ SF SALINE SYRINGE SALINE FLUSH NGT BECTON, DICKINSON AND CO. SEE SECTION H.10. 30382903065531

    Patients

    Seq Age Sex Outcome Treatment
    1 Other