BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE FILTER BLUNT FILL 18X1-1/2

    MDR report key: 11051910 · Received December 21, 2020

    Report

    Report Number
    2243072-2020-02100
    Event Type
    Malfunction
    Date Received
    December 21, 2020
    Date of Event
    November 23, 2020
    Report Date
    January 8, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED WITH ADDITIONAL INFORMATION: B.5. EVENT DESCRIPTION: IT WAS REPORTED THAT A NEEDLE FILTER BLUNT FILL 18X1-1/2 WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL NO: UNKNOWN. BATCH NO: UNKNOWN. IT WAS REPORTED THAT AFTER THE THE NEEDLE FILTER WAS CLOGGED. EVENT DESCRIPTION PER EMAIL STATES: ¿DURING THE CUSTOMER EXTRACTED THE SOLUTION FROM THE VIAL TO THE SYRINGED, THE FILTER NEEDLE WAS CLOGGED DUE TO UNKNOWN AIR PRESSURE. SO THE CUSTOMER FAILED TO MOVE THE SOLUTION TO THE SYRINGED..¿" D.1. BRAND NAME: NEEDLE FILTER BLUNT FILL 18X1-1/2 D.2. TYPE OF DEVICE: GAA; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE D.3. MANUFACTURER NAME: BD MEDICAL (BD WEST) MEDICAL SURGICAL D.4. CATALOG NUMBER: 305211; LOT NUMBER: 8090621; EXPIRATION DATE: 2023-05-31 H.4. DEVICE MANUFACTURE DATE: 2018-03-31 G.1. MANUFACTURING SITE: BD MEDICAL (BD WEST) MEDICAL SURGICAL G.5. 510K NUMBER: EXEMPT.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 8090621. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS INCIDENT, 4 PHOTOS WERE PROVIDED. THEY SHOW A VIAL FROM DIFFERENT ANGLES. NOT CLEAR THE REASON SHOWING IT. THE CAUSE FOR THIS DEFECT COULD NOT BE DETERMINED BASED ON THE PICTURES PROVIDED. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NEEDLE FILTER BLUNT FILL 18X1-1/2 WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN IT WAS REPORTED THAT AFTER THE THE NEEDLE FILTER WAS CLOGGED. EVENT DESCRIPTION PER EMAIL STATES: ¿DURING THE CUSTOMER EXTRACTED THE SOLUTION FROM THE VIAL TO THE SYRINGED, THE FILTER NEEDLE WAS CLOGGED DUE TO UNKNOWN AIR PRESSURE. SO THE CUSTOMER FAILED TO MOVE THE SOLUTION TO THE SYRINGED.¿

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NEEDLE FILTER BLUNT FILL 18X1-1/2 WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL NO: UNKNOWN. BATCH NO: UNKNOWN. IT WAS REPORTED THAT AFTER THE THE NEEDLE FILTER WAS CLOGGED. EVENT DESCRIPTION PER EMAIL STATES: ¿DURING THE CUSTOMER EXTRACTED THE SOLUTION FROM THE VIAL TO THE SYRINGED, THE FILTER NEEDLE WAS CLOGGED DUE TO UNKNOWN AIR PRESSURE. SO THE CUSTOMER FAILED TO MOVE THE SOLUTION TO THE SYRINGED..¿"

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4). UNKNOWN MANUFACTURER: (B)(4). INVESTIGATION SUMMARY: SINCE NO ACTUAL SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED BD NEEDLE WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN. IT WAS REPORTED THAT AFTER THE NEEDLE FILTER WAS CLOGGED. EVENT DESCRIPTION PER EMAIL STATES: ¿DURING THE CUSTOMER EXTRACTED THE SOLUTION FROM THE VIAL TO THE SYRINGED, THE FILTER NEEDLE WAS CLOGGED DUE TO UNKNOWN AIR PRESSURE. SO THE CUSTOMER FAILED TO MOVE THE SOLUTION TO THE SYRINGED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1509214 NEEDLE FILTER BLUNT FILL 18X1-1/2 MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 8090621

    Patients

    Seq Age Sex Outcome Treatment
    1