BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL S/C 48

    MDR report key: 20333581 · Received September 30, 2024

    Report

    Report Number
    1911916-2024-00704
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    September 25, 2024
    Report Date
    October 10, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903028307
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP: IT WAS REPORTED THE MARKINGS WERE MISSING ON SYRINGES. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS TWO SYRINGES WITH A SCALE MARKING ISSUE. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THERE WAS A JAM DURING THE SYRINGE BARREL PRINTING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302830, LOT 4122281. 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 SYRINGE BARREL PRINTING PROCESS WAS PERFORMED. THE SETTINGS WERE CORRECT, AND THE 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.

    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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. MATERIAL # 302830; BATCH # 4122281. IT WAS REPORTED BY CUSTOMER THAT THE MARKINGS ON THE SYRINGES WE RECEIVED WERE MISSING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. I AM REACHING OUT TO REPORT AN ISSUE WITH OUR 20 ML SYRINGES. NOT SURE IF ANY OTHER INSTITUTIONS HAD REPORTED THIS ISSUE BUT THE MARKINGS ON THE SYRINGES WE RECEIVED WERE MISSING. CUSTOMER RESPONSE ON SEP 27, 2024: 1. THE DEFECT WAS OBSERVED ON 09/25/2024 BEFORE USE. 2. NO IMPACT TO PATIENT SINCE WE DISPOSE OF SYRINGE BEFORE STARTING TO COMPOUND. 3. EXACT DATE 09/25/2024. 4. LOT NUMBER 4122281.

    Description of Event or Problem · 0

    MATERIAL # 302830. BATCH # 4122281. IT WAS REPORTED BY CUSTOMER THAT THE MARKINGS ON THE SYRINGES WE RECEIVED WERE MISSING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I AM REACHING OUT TO REPORT AN ISSUE WITH OUR 20 ML SYRINGES. NOT SURE IF ANY OTHER INSTITUTIONS HAD REPORTED THIS ISSUE BUT THE MARKINGS ON THE SYRINGES WE RECEIVED WERE MISSING. CUSTOMER RESPONSE ON SEP 27, 2024 THE DEFECT WAS OBSERVED ON 09/25/24 BEFORE USE. NO IMPACT TO PATIENT SINCE WE DISPOSE OF SYRINGE BEFORE STARTING TO COMPOUND. EXACT DATE 09/25/2024. LOT NUMBER 4122281.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1054019 SYRINGE 20ML LL S/C 48 SYRINGE, PISTON FMF BECTON DICKINSON 4122281 30382903028307

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown