BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML BD LUER-LOK LUER-LOK TIP

    MDR report key: 8853407 · Received August 1, 2019

    Report

    Report Number
    2243072-2019-01568
    Event Type
    Malfunction
    Date Received
    August 1, 2019
    Date of Event
    July 11, 2019
    Report Date
    October 29, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CHANGES ARE AS FOLLOWS: 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 FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. D.4 MEDICAL DEVICE CATALOG #: 309657. D.2. COMMON DEVICE NAME: PISTON SYRINGE. D.1 MEDICAL DEVICE TYPE: FMF . G.5. PMA / 510(K)#: K980987 OR K151766 H3 OTHER TEXT : SEE. H.10.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE SAMPLE RECEIVED FOR INVESTIGATION. THE EVALUATION OF THE SAMPLE IS CARRIED OUT ACCORDING TO THE ESTABLISHED TESTS AND METHODS, INCLUDING VISUAL EVALUATION OF THE BARREL TO CHECK FOR DAMAGE, LEAKAGE WITH MAXZER DEVICE, DEFORMITY OF THE BARREL, AND MOLDING DEFECT OF SYRINGE. NO DEFECTS WERE DETECTED, RESULTS WERE COMPLIANT. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED. HOWEVER, BY REVIEWING THE NON-CONFORMITIES GENERATED IN THE MANUFACTURING PROCESS WITHIN A 12-MONTH PERIOD TO CHECK FOR SIMILAR EVENTS OR LEAKING PROBLEMS, THERE ARE NO OPEN QUALITY NOTIFICATIONS FOR THIS DEFECT. THE DEFECT WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. AT THIS TIME, NO CORRECTIVE ACTIONS ARE NECESSARY. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OCCURRED WITH A 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE NICU AT HAD JUST INFORMED ME OF SEVERAL LEAKING INCIDENTS THAT HAVE OCCURRED WHEN USING A 3ML SYRINGE WITH OUR BD MAXPLUS CONNECTOR (ITEM #MP1000-C). ESTIMATES THAT THE LEAKING HAS OCCURRED 6 OR 7 TIMES OVER THE LAST 6 MONTHS, BUT DID NOT THINK TO REPORT IT UNTIL NOW, AS IT WASN¿T A REGULAR OCCURRENCE." 7 OCCURRENCES WERE REPORTED, BUT THE DATE/TIME AND PATIENT INFORMATION WERE NOT GIVEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OCCURRED WITH A 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE NICU AT HAD JUST INFORMED ME OF SEVERAL LEAKING INCIDENTS THAT HAVE OCCURRED WHEN USING A 3ML SYRINGE WITH OUR BD MAXPLUS CONNECTOR (ITEM #MP1000-C). ESTIMATES THAT THE LEAKING HAS OCCURRED 6 OR 7 TIMES OVER THE LAST 6 MONTHS, BUT DID NOT THINK TO REPORT IT UNTIL NOW, AS IT WASN¿T A REGULAR OCCURRENCE." 7 OCCURRENCES WERE REPORTED, BUT THE DATE/TIME AND PATIENT INFORMATION WERE NOT GIVEN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 LEAKAGE OCCURRED WITH A UNSPECIFIED BD CONNECTOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE NICU AT HAD JUST INFORMED ME OF SEVERAL LEAKING INCIDENTS THAT HAVE OCCURRED WHEN USING A 3 ML SYRINGE WITH OUR BD MAXPLUS CONNECTOR (ITEM #MP1000-C). ESTIMATES THAT THE LEAKING HAS OCCURRED 6 OR 7 TIMES OVER THE LAST 6 MONTHS, BUT DID NOT THINK TO REPORT IT UNTIL NOW, AS IT WASN'T A REGULAR OCCURRENCE." 7 OCCURRENCES WERE REPORTED, BUT THE DATE/TIME AND PATIENT INFORMATION WERE NOT GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647133 3 ML BD LUER-LOK LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other