BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 9457847 · Received December 12, 2019

    Report

    Report Number
    2243072-2019-02794
    Event Type
    Malfunction
    Date Received
    December 12, 2019
    Date of Event
    November 26, 2019
    Report Date
    December 3, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    NGT
    UDI-DI
    30382903065463
    PMA / PMN Number
    SEE H.10.
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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 ((B)(4)). PMA / 510(K)#: K141311 ((B)(4)). INVESTIGATION SUMMARY: ONE PHOTO WAS PROVIDED. THE PHOTO SHOWS A SYRINGE THAT SAYS IN THE BARREL LABEL: ¿TEETH WHITENING GEL DENTAL PROFESSIONAL STRENGTH¿. THIS IS NOT A BD PRODUCT. BD DOESN¿T PRODUCE IT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. A DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. INVESTIGATION CONCLUSION: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE WITH THE SAMPLE PROVIDED. ROOT CAUSE DESCRIPTION: ROOT CAUSE IS UNDETERMINED. 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 THE PATIENT PULLED A SYRINGE OUT OF THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE BOX THAT WAS LABELED "TEETH WHITENING GEL" BEFORE USE WHEN PREPARING TO FLUSH HIS LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A PATIENT REPORTED THAT WHEN HE WENT TO FLUSH HIS LINE, HE GRABBED A SYRINGE OUT OF THE BOX LABELED # 306546- SYRINGE 10ML REG PR SALINE 10ML FILL AND WHAT HE GRABBED WAS A SYRINGE LABELED WITH "TEETH WHITENING GEL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257866 BD POSIFLUSH¿ NORMAL SALINE SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BECTON DICKINSON UNKNOWN 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Other