BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NS FILLED SYRINGE

    MDR report key: 8233236 · Received January 10, 2019

    Report

    Report Number
    9616657-2018-00091
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Date of Event
    December 18, 2018
    Report Date
    February 15, 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

    INVESTIGATION: LOT NUMBERS 8192986 AND 8232966 WERE PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR EACH PROVIDED LOT NUMBER AND THE REVIEWS DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. SAMPLES WERE RECEIVED FOR LOT NUMBER 8232966. THROUGH INSPECTION OF THE RETURNED SAMPLES, OUR QUALITY ENGINEER TEAM OBSERVED EXCESS MATERIAL/PLASTIC ATTACHED TO THE TIP OF THE BARRELS. 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. BATCH CODE: 8192986: BASED ON THE INVESTIGATION, THE ROOT CAUSE CANNOT BE DETERMINED AS A SAMPLE WAS NOT PROVIDED. BATCH CODE: 8232966: THE ROOT CAUSE MAY BE RELATED TO MOULDING PIN WEAR AND INSPECTION AND DETECTION METHODOLOGY INADEQUACY ON THE MOULDING MACHINE.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD POSIFLUSH¿ NS FILLED SYRINGE THERE WERE 2 ISSUES OF AN EXTRA PIECE OF SHARP PLASTIC ON THE TIP OF THE SYRINGE. THIS HAPPENED ONCE WITH LOT# 8232966 AND ONCE WITH LOT# 8192986.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8232966; MEDICAL DEVICE EXPIRATION DATE: 2021-07-31; DEVICE MANUFACTURE DATE: 2018-08-20; MEDICAL DEVICE LOT #: 8192986; MEDICAL DEVICE EXPIRATION DATE: 2021-06-30; DEVICE MANUFACTURE DATE: 2018-07-11. 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 WITH THE USE OF THE BD POSIFLUSH¿ NS FILLED SYRINGE THERE WERE 2 ISSUES OF AN EXTRA PIECE OF SHARP PLASTIC ON THE TIP OF THE SYRINGE. THIS HAPPENED ONCE WITH LOT# 8232966 AND ONCE WITH LOT# 8192986.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28072 BD POSIFLUSH¿ NS FILLED SYRINGE FLUSH NGT BECTON, DICKINSON AND CO. SEE H.10 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Other