BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML REG PR SALINE FILL SPKG

    MDR report key: 10399843 · Received August 12, 2020

    Report

    Report Number
    9616657-2020-00120
    Event Type
    Malfunction
    Date Received
    August 12, 2020
    Date of Event
    July 6, 2020
    Report Date
    November 18, 2020
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    UDI-DI
    30382903065531
    PMA / PMN Number
    K153481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 0044535 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, BOTH PICTURE AND PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLES, DAMAGE WAS OBSERVED TO THE PRODUCT PACKAGING. THE OBSERVED DAMAGE WAS ADDRESSED WITH THE MANUFACTURING PLANT'S ENGINEERING LEADERSHIP TEAM; HOWEVER, THROUGH REVIEW, AN EXACT CAUSE COULD NOT BE ASSIGNED AT THIS TIME. IN RESPONSE TO THIS INCIDENT, A CORRECTIVE AND PREVENTIVE ACTION PLAN CAPA 1833142 HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS ISSUE, IDENTIFY AN EXACT CAUSE, AND PREVENT THIS ISSUE FROM RECURRING. ASSESSMENTS ARE CURRENTLY BEING PERFORMED WITH A PRIMARY FOCUS ON THE HANDLING AND PACKAGING PROCESS OF THE BLISTER PACKAGES. OUR QUALITY TEAM WILL CLOSELY MONITOR THE PRODUCTION PROCESS FOR SIGNS OF THIS TYPE OF DAMAGE AND ANY EMERGING TRENDS. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STERILE PACKAGING WAS COMPROMISED WITH 29 BD SYRINGE 10ML REG PR SALINE FILL SPKG. THIS WAS DISCOVERED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2 COMPLAINTS) IT WAS REPORTED THAT THE STERILE SALINE SYRINGES HAVE A TEAR IN THE POUCH.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STERILE PACKAGING WAS COMPROMISED WITH 29 BD SYRINGE 10 ML REG PR SALINE FILL SPKG. THIS WAS DISCOVERED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2 COMPLAINTS) IT WAS REPORTED THAT THE STERILE SALINE SYRINGES HAVE A TEAR IN THE POUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864024 BD SYRINGE 10ML REG PR SALINE FILL SPKG INTRAVASCULAR CATHETER NGT BECTON, DICKINSON AND CO. 306553 0044535 30382903065531

    Patients

    Seq Age Sex Outcome Treatment
    1 Other