BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML S/T W/NDL 27X1/2 RB

    MDR report key: 18184592 · Received November 21, 2023

    Report

    Report Number
    1213809-2023-01315
    Event Type
    Malfunction
    Date Received
    November 21, 2023
    Date of Event
    October 27, 2023
    Report Date
    March 5, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903096238
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR 9150012 ¿ FOLLOW UP MDR FOR DEVICE EVALUATION NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS OF THE AFFECTED DEVICE. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. WE REGRET ANY INCONVENIENCES THIS INCIDENT MAY HAVE CAUSED YOU AND YOUR FACILITY. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE

    Additional Manufacturer Narrative · 0

    PR (B)(4) : INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD. PATIENT PROBLEM CODE: F26 ¿ NO HEALTH CONSEQUENCES OR IMPACT. DEVICE PROBLEM CODE: A0407 - MATERIAL DISCOLORED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION

    Description of Event or Problem · 0

    MAT# 309623. BATCH# 3181148. IT WAS REPORTED BY THE CUSTOMER THAT THE PRODUCT IS VERY FLIMSY, AND THE INSIDE OF THE CLEAR PACKAGING IS CLOUDY. VERBATIM: COMPLAINT RECEIVED VIA EMAIL. EMAIL(S) ATTACHED. ITEM: 309623. QUANTITY AFFECTED: 1 CS. SERIAL/LOT NUMBER: (B)(6). PO : (B)(6). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: WE HAVE RECEIVED SOME COMPLAINTS FROM CLINICS ON THE QUALITY OF WHAT WE HAVE BEEN RECEIVING. COMMENTS ARE ¿ VERY FLIMSY, AND THE INSIDE OF THE CLEAR PACKAGING IS CLOUDY. HAVE YOU GOTTEN COMPLAINTS FROM ANYONE ELSE. WE ARE CONCERNED THAT IF WE ORDER MORE WE WILL GET THE SAME THING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1854929 SYRINGE 1ML S/T W/NDL 27X1/2 RB SYRINGE, PISTON FMF BECTON DICKINSON 3181148 30382903096238

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown