BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML REG PR SALINE 10ML FILL

    MDR report key: 8241072 · Received January 11, 2019

    Report

    Report Number
    9616657-2018-00082
    Event Type
    Malfunction
    Date Received
    January 11, 2019
    Date of Event
    December 18, 2018
    Report Date
    February 8, 2019
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    UDI-DI
    30382903065463
    PMA / PMN Number
    K141311
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THROUGH EVALUATION OF THE RETURNED SAMPLE UNITS, OUR QUALITY ENGINEER TEAM OBSERVED EXCESS MATERIAL/PLASTIC ATTACHED TO THE TIP OF THE BARRELS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 8232966 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. IT HAS BEEN DETERMINED THAT THIS INCIDENT MOST LIKELY RESULTED FROM A MOLDING PROCESS ERROR THAT WENT UNDETECTED DUE TO INADEQUATE INSPECTION AND DETECTION METHODOLOGIES WITHIN THE MOLDING MACHINE. IN RESPONSE TO THIS ISSUE, THE CURRENT INSPECTION AND DETECTION ACTIVITIES ARE UNDER REVIEW TO DETERMINE ADEQUACY. A CORRECTIVE AND PREVENTIVE ACTION PLAN HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS ISSUE AND PREVENT ITS RECURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD POSIFLUSH¿ NS FILLED SYRINGE THERE WERE 2 ISSUES WITH PIECE OF PLASTIC ATTACHED TO INSERTION TIP.

    Additional Manufacturer Narrative · 1

    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 A SYRINGE 10ML REG PR SALINE 10ML FILL HAD A JAGGED PIECE OF PLASTIC ATTACHED TO THE INSERTION TIP. THIS OCCURRED ON 4 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32183 SYRINGE 10ML REG PR SALINE 10ML FILL POSIFLUSH SP NGT BECTON, DICKINSON AND CO. 8232966 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Other