BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDLE 25GA 7/8IN ECG BLT NO-ANL TRANS ORN

    MDR report key: 8348656 · Received February 18, 2019

    Report

    Report Number
    2243072-2019-00270
    Event Type
    Malfunction
    Date Received
    February 18, 2019
    Date of Event
    January 30, 2019
    Report Date
    March 4, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WITH THE USE OF THE NDLE 25GA 7/8IN ECG BLT NO-ANL TRANS ORN THERE WAS AN ISSUE WITH FOREIGN MATTER FOUND ON ABOUT 200000 NEEDLES. D.1. MEDICAL DEVICE BRAND NAME: NDLE 25GA 7/8IN ECG BLT NO-ANL TRANS ORN. D.3. MEDICAL DEVICE MANUFACTURER: BD MEDICAL (BD WEST) MEDICAL SURGICAL. D.4. MEDICAL DEVICE CATALOG #: 302902. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). D.4. MEDICAL DEVICE EXPIRATION DATE: N/A. G.1. MANUFACTURING LOCATION: BD MEDICAL (BD WEST) MEDICAL SURGICAL. G.5. PMA / 510(K)#: K021475. H.4. DEVICE MANUFACTURE DATE: 1/17/2018

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT AND ROOT CAUSE COULD BE DETERMINED. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE NDLE 25GA 7/8IN ECG BLT NO-ANL TRANS ORN THERE WAS AN ISSUE WITH FOREIGN MATTER FOUND ON ABOUT 200000 NEEDLES.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE UNSPECIFIED BD¿ NEEDLE THERE WAS AN ISSUE WITH FOREIGN MATTER FOUND ON THE NEEDLE.

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG 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. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. INITIAL REPORTER: ADDRESS UNAVAILABLE. BD CORPORATE ADDRESS USED. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE UNSPECIFIED BD¿ NEEDLE THERE WAS AN ISSUE WITH FOREIGN MATTER FOUND ON THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139976 NDLE 25GA 7/8IN ECG BLT NO-ANL TRANS ORN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 8017688

    Patients

    Seq Age Sex Outcome Treatment
    1 Other