BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 9432720 · Received December 6, 2019

    Report

    Report Number
    9616657-2019-00382
    Event Type
    Malfunction
    Date Received
    December 6, 2019
    Date of Event
    November 20, 2019
    Report Date
    February 5, 2020
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    UDI-DI
    30382903065463
    PMA / PMN Number
    K161552
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 9231003 AND THE REVIEW DID NOT REVEAL ANY DETECTED NON-CONFORMANCES DURING THE PRODUCTION PROCESS. TO FURTHER INVESTIGATE THIS ISSUE, ONE PHYSICAL SAMPLE WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. WITHIN THE PRODUCTION FACILITY, THERE WAS RECORD OF INTERMITTENT ISSUES WITH THE SILICONE SUPPLY HOSING IN THE MANUFACTURING PROCESS. ALL PRODUCT ASSOCIATED WITH THIS ISSUE WAS HELD FOR INSPECTION AND THE AFFECTED MATERIAL WAS SCRAPPED. IT IS POSSIBLE THAT THIS INCIDENT RESULTED FROM UNDETECTED AFFECTED PRODUCT MOVING FORWARD THROUGH THE PRODUCTION PROCESS DURING THE PRODUCTION OF LOT 9231003. CORRECTIONS HAVE BEEN MADE TO THE SILICONE HOSING EQUIPMENT TO PREVENT THIS ISSUE FROM RECURRING. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE PRODUCTION PROCESS FOR DEFECTS SUCH AS THIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DIFFICULT PLUNGER WAS FOUND DURING USE WITH A 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE PLUNGER IN THE SYRINGE WAS UNABLE TO BE PUSHED TO DELIVER THE SALINE." 3 OCCURRENCES WERE REPORTED

    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 DIFFICULT PLUNGER WAS FOUND DURING USE WITH A 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE PLUNGER IN THE SYRINGE WAS UNABLE TO BE PUSHED TO DELIVER THE SALINE." 3 OCCURRENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229125 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE FLUSH SYRINGE NGT BECTON, DICKINSON AND CO. 306546 9231003 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Other