BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 8773678 · Received July 9, 2019

    Report

    Report Number
    9616657-2019-00251
    Event Type
    Malfunction
    Date Received
    July 9, 2019
    Date of Event
    June 20, 2019
    Report Date
    June 21, 2019
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    UDI-DI
    30382903065463
    PMA / PMN Number
    SEE H.10.
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE PMA / 510(K)#S REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: PMA / 510(K)#: K161552. PMA / 510(K)#: K141311. INVESTIGATION SUMMARY: BD WAS UNABLE TO VERIFY OR DETERMINE THE ROOT CAUSE OF THE REPORTED COMPLAINT OF LEAKAGE DUE TO THE RETURNING SAMPLE BEING CONTAMINATED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. INVESTIGATION CONCLUSION: THE SAMPLE RECEIVED WAS CONTAMINATED THEREFORE A COMPLAINT ANALYSIS COULD NOT BE PERFORMED. ROOT CAUSE DESCRIPTION: THE SAMPLE RECEIVED WAS CONTAMINATED THEREFORE A COMPLAINT ANALYSIS COULD NOT BE PERFORMED. AN INVESTIGATION COULD NOT BE COMPLETED, AND A ROOT CAUSE IS UNASSIGNABLE IN THIS CASE. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SALINE LEAKED PAST THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE STOPPER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NURSE WITNESSED THE SALINE FLUID LEAKING ABOVE PLUNGER AREA OF THE SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564060 BD POSIFLUSH¿ NORMAL SALINE SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 9065683 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Other