BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH NORMAL SALINE SYRINGE

    MDR report key: 12283165 · Received August 5, 2021

    Report

    Report Number
    9616657-2021-00071
    Event Type
    Malfunction
    Date Received
    August 5, 2021
    Date of Event
    July 7, 2021
    Report Date
    July 27, 2021
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    UDI-DI
    30382903065463
    PMA / PMN Number
    K141311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1111072. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. HOWEVER, A MAINTENANCE INTERVENTION WAS PERFORMED FOR A POTENTIALLY RELATED DEFECT, BUT THE INTERVENTION WAS COMPLETED PRIOR TO ANY PRODUCT BECOMING AFFECTED. TO AID IN THE INVESTIGATION OF THIS ISSUE, PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLES, PLUNGER MOVEMENT DIFFICULTY WAS CONFIRMED. IT HAS BEEN DETERMINED THAT THIS INCIDENT WAS A RESULT OF AN ISOLATED OCCURRENCE ON THE MANUFACTURING LINE RELATED TO THE SILICONIZATION PROCESS. A CORRECTION WAS MADE TO RESOLVE THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE PLUNGER WOULD NOT FULLY DEPRESS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE RECEIVED A COMPLAINT FROM A CLINICAL AREA AT THE SYRINGE DOES NOT FULLY DEPRESS, LEAVING SALINE IN THE SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180118 BD POSIFLUSH NORMAL SALINE SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 306546 1111072 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1