BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL S/C 48

    MDR report key: 19433988 · Received May 31, 2024

    Report

    Report Number
    1911916-2024-00393
    Event Type
    Malfunction
    Date Received
    May 31, 2024
    Date of Event
    May 28, 2024
    Report Date
    June 5, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903028307
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    PR 10265349 FOLLOW UP. IT WAS REPORTED THE PRODUCT HAS LITTLE TO NO PRODUCT PRINT ON THEM. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A PACKAGING BLISTER TOP WEB WITH MISSING PRINT. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THE PACKAGING TOP WEB PRINTER HEADS BECAME CLOGGED INDUCING THE SYMPTOM REPORTED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302830, LOT 4080764. 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. VERIFICATION OF THE PACKAGING PRINTING PROCESS WAS PERFORMED. THE PRINTING AND FLOW OF PRODUCT WAS GOOD. 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 IS CONFIRMED.

    Description of Event or Problem · 0

    MATERIAL # 302830. LOT # 4080764. IT WAS REPORTED BY CUSTOMER THAT THE 1ST TWO LAYERS OF PRODUCT HAVE LITTLE TO NO PRODUCT PRINT ON THEM. VERBATIM: UPON OPENING A SEALED CASE OF 4 BOXES OF # 302830 ¿ 20ML LL SYRINGE, IT IS NOTED THAT THE 1ST TWO LAYERS OF PRODUCT HAVE LITTLE TO NO PRODUCT PRINT ON THEM. SEE PICS BELOW. LOT # 4080764. WE WILL USE THEM BUT WANTED TO ALERT BD. WE DO HAVE OTHER LOOSE BOXES OF SAME LOT # ON SHELF ALREADY, AND THEY ARE ALL FINE. JUST REPORTING IN CASE OTHER CUSTOMERS REPORT SAME. ADDITIONAL INFORMATION: THE MISS-PRINTED SYRINGE PACKAGING WAS DISCOVERED BY MATERIALS MANAGEMENT STAFF YESTERDAY, 05/28/2024 AND ITEM DIDN¿T MAKE IT TO THE NURSING FLOOR. NO HARM TO PATIENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED THE MISS-PRINTED SYRINGE PACKAGING WAS DISCOVERED BY MATERIALS MANAGEMENT STAFF YESTERDAY, 05/28/2024 AND ITEM DIDN¿T MAKE IT TO THE NURSING FLOOR. NO HARM TO PATIENT MATERIAL # 302830. LOT # 4080764. IT WAS REPORTED BY CUSTOMER THAT THE 1ST TWO LAYERS OF PRODUCT HAVE LITTLE TO NO PRODUCT PRINT ON THEM. VERBATIM: UPON OPENING A SEALED CASE OF 4 BOXES OF # 302830 ¿ 20ML LL SYRINGE, IT IS NOTED THAT THE 1ST TWO LAYERS OF PRODUCT HAVE LITTLE TO NO PRODUCT PRINT ON THEM. SEE PICS BELOW. LOT # 4080764. WE WILL USE THEM BUT WANTED TO ALERT BD. WE DO HAVE OTHER LOOSE BOXES OF SAME LOT # ON SHELF ALREADY, AND THEY ARE ALL FINE. JUST REPORTING IN CASE OTHER CUSTOMERS REPORT SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299239 SYRINGE 20ML LL S/C 48 SYRINGE, PISTON FMF BECTON DICKINSON 4080764 30382903028307

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown