BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 8646420 · Received May 28, 2019

    Report

    Report Number
    1911916-2019-00523
    Event Type
    Malfunction
    Date Received
    May 28, 2019
    Date of Event
    October 16, 2017
    Report Date
    May 15, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    30382903065470
    PMA / PMN Number
    K161552
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO SAMPLES WERE RECEIVED. NO PHOTOS WERE PROVIDED. 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: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. THIS IS THE 1ST COMPLAINT FOR LOT # 7163656 FOR THIS TYPE OF DEFECT OR SYMPTOM. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. 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 WHILE DRAWING UP BLOOD FROM A HEMODIALYSIS CENTRAL LINE, BLOOD LEAKED BEHIND AND INSIDE THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE PLUNGER'S STOPPER, AND DRIPPED DOWN IT ONTO THE STAFF MEMBER'S GLOVES. THIS COMPLAINT WAS CREATED TO CAPTURE 2ND OF 12 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN WITHDRAWING BLOOD FROM A HEMODIALYSIS CENTRAL LINE, BLOOD GOT BEHIND AND INSIDE THE LARGER RUBBER TIP OF THE PLUNGER. SUBSEQUENTLY BLOOD DRIPPED DOWN THE PLUNGER AND ONTO THE STAFF MEMBERS GLOVES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438017 BD POSIFLUSH¿ NORMAL SALINE SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 7163656 30382903065470

    Patients

    Seq Age Sex Outcome Treatment
    1 Other