BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 BLUNT FILL

    MDR report key: 18533868 · Received January 18, 2024

    Report

    Report Number
    1911916-2024-00018
    Event Type
    Malfunction
    Date Received
    January 18, 2024
    Date of Event
    December 21, 2023
    Report Date
    July 31, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    GAA
    UDI-DI
    30382903051800
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED A MEDICATION THAT WAS CLEAR TURNED RED WHEN PULLED INTO BD SYRINGE WITH A BD NEEDLE. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE COMPLETED. TO AID IN THE INVESTIGATION, FIVE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. ONE PHOTO SHOWS A NEEDLE ASSEMBLY WITH THE PLASTIC SHIELD CONNECTED TO AN EMPTY SYRINGE. THE SYRINGE APPEARS TO HAVE THE PLUNGER ROD-RUBBER STOPPER ALL THE DOWN. THE SECOND PHOTO SHOWS A PACKAGING BLISTER TOP WEB. THE ADDITIONAL THREE PHOTOS SHOW A VIAL. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTOS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305180, LOT 3181357. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED, AND WITHOUT THE ACTUAL SAMPLE ANALYSIS A PROBABLE ROOT CAUSE COULD NOT BE OFFERED. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. 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 · 0

    MATERIALS#: 305180 BATCH#: 3181357. IT WAS REPORTED BY THE CUSTOMER THAT STATED HUB OF THE NEEDLE IS RED, MAY BE SOME SORT OF DYE. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. (B)(6). EVENT INVOLVING BD NEEDLE AND SYRINGE AND DIFFERENT SUPPLIER MEDICATION VIAL HAS REPORTED THIS THROUGH MEDSUN (EXTERNAL REF. (B)(4) SHOULD BE GETTING REPORT THROUGH FDA MEDWATCH AS WELL. (CHECK FOR DUPES). BD NEEDLE-305180 LOT 3181357 EXP 8/31/2028 (PULLED LOT OUT OF CIRCULATION) STATED HUB OF THE NEEDLE IS RED, MAY BE SOME SORT OF DYE? SYRINGE-309657 LOT 3219780 EXP 7/31/2028. ISSUE: NURSE USED BD NEEDLE AND BD SYRINGE TO PULL UP A VIAL OF MEDICATION THAT WAS CLEAR AND THEN IT TURNED RED WHEN PULLED INTO BD SYRINGE. NO ADVERSE EVENTS TO PATIENT DATE OF EVENT 12/21/2023. SEQUESTERED IMPACTED PRODUCT AND HAS PHOTOS, LET ME KNOW SHE HAS SPOKEN TO MANUFACTURER OF MEDICATION VIAL AND VIAL WILL BE RETURNED TO THEM AND OUR PRODUCT TO US, WAS CONCERNED IF WE WOULD ALSO NEED VIAL TO INVESTIGATE ISSUE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1713112 NEEDLE 18X1-1/2 BLUNT FILL NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BECTON DICKINSON 3181357 30382903051800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown