BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 25X1-1/2 RB

    MDR report key: 8764694 · Received July 5, 2019

    Report

    Report Number
    1911916-2019-00667
    Event Type
    Malfunction
    Date Received
    July 5, 2019
    Date of Event
    June 19, 2019
    Report Date
    August 19, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051275
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES OR PHOTOS WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. WHILE A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, FOREIGN MATERIAL (FM) CAN BE INTRODUCED TO THE FLUID PATH DURING THE MANUFACTURING PROCESS WHICH COULD CAUSE THE NEEDLE TO BECOME CLOGGED. ALL PRODUCT IS AUTOMATICALLY CHECKED FOR CLOGGED NEEDLES DURING THE PRODUCTION PROCESS. 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 WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE NEEDLE 25X1-1/2 RB EXPERIENCED A CLOGGED/BLOCKED NEEDLE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305127 BATCH NO: 6152724 IT WAS REPORTED THAT THERE WAS NO HOLE IN THE NEEDLE. EVENT DESCRIPTION PER SNOW CASE STATES, "REF: 305127 LOT: 8144894 EXPIRATION DATE: 2023-07-31 CONSUMER REPORTED THERE WAS "NO HOLE" IN NEEDLE, WAS NOT ABLE TO DRAW MEDICATION. STATED INCIDENT ONLY OCCURRED ONCE AND DOES NOT KNOW OCCURRENCE DATE. SAMPLE AVAILABLE. SAMPLE FOR CS0011594 COMING IN WITH THIS FILE" LOT NUMBER UPDATED PER SAMPLE RECEIVED AND FOLLOW UP BETWEEN US COM AND CONSUMER, "FILE HAS BEEN UPDATED. CONSUMER COULD NOT REMEMBER LOTS SHE PROVIDED AND CONSEQUENTLY, DID NOT HAVE THE BOXES FROM ORIGINAL COMPLAINT." D.4. MEDICAL DEVICE LOT #: 6152724 D.4. MEDICAL DEVICE EXPIRATION DATE: 7/31/2021 H.4. DEVICE MANUFACTURE DATE: 5/31/2016 H.6. INVESTIGATION SUMMARY: TWO (2) SAMPLES WERE RETURNED FROM THE CUSTOMER FOR INVESTIGATION. THE SAMPLES WERE VISUALLY EXAMINED AND WERE FOUND TO BE CLOGGED AS LIGHT WAS NOT ABLE TO PASS THROUGH THE NEEDLES. FOREIGN MATERIAL (FM) CAN BE INTRODUCED TO THE FLUID PATH DURING THE MANUFACTURING PROCESS WHICH COULD CAUSE THE NEEDLE TO BECOME CLOGGED. ALL PRODUCT IS AUTOMATICALLY CHECKED FOR CLOGGED NEEDLES DURING THE PRODUCTION PROCESS. 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 WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. H3 OTHER TEXT : SEE SECTION H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE 25X1-1/2 RB EXPERIENCED A CLOGGED/BLOCKED NEEDLE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305127 BATCH NO: 8144894 EVENT DESCRIPTION: MATERIAL: 305127. LOT: 8144894. EXPIRATION DATE: 2023-07-31. CONSUMER REPORTED THERE WAS "NO HOLE" IN NEEDLE, WAS NOT ABLE TO DRAW MEDICATION. STATED INCIDENT ONLY OCCURRED ONCE AND DOES NOT KNOW OCCURRENCE DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE 25X1-1/2 RB EXPERIENCED A CLOGGED/BLOCKED NEEDLE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305127; BATCH NO: 6152724. IT WAS REPORTED THAT THERE WAS NO HOLE IN THE NEEDLE. EVENT DESCRIPTION PER SNOW CASE STATES, "REF: 305127; LOT: 8144894; EXPIRATION DATE: 2023-07-31. CONSUMER REPORTED THERE WAS "NO HOLE" IN NEEDLE, WAS NOT ABLE TO DRAW MEDICATION. STATED INCIDENT ONLY OCCURRED ONCE AND DOES NOT KNOW OCCURRENCE DATE. SAMPLE AVAILABLE. SAMPLE FOR (B)(6) COMING IN WITH THIS FILE" LOT NUMBER UPDATED PER SAMPLE RECEIVED AND FOLLOW UP BETWEEN US COM AND CONSUMER, "FILE HAS BEEN UPDATED. CONSUMER COULD NOT REMEMBER LOTS SHE PROVIDED AND CONSEQUENTLY, DID NOT HAVE THE BOXES FROM ORIGINAL COMPLAINT."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EVALUATED BY MFR: 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 THE NEEDLE 25X1-1/2 RB EXPERIENCED A CLOGGED/BLOCKED NEEDLE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305127, BATCH NO: 8144894. EVENT DESCRIPTION: MATERIAL: 305127, LOT: 8144894, EXPIRATION DATE: 2023-07-31. CONSUMER REPORTED THERE WAS "NO HOLE" IN NEEDLE, WAS NOT ABLE TO DRAW MEDICATION. STATED INCIDENT ONLY OCCURRED ONCE AND DOES NOT KNOW OCCURRENCE DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559286 NEEDLE 25X1-1/2 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 6152724 30382903051275

    Patients

    Seq Age Sex Outcome Treatment
    1 Other