BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL BNS

    MDR report key: 20651189 · Received November 11, 2024

    Report

    Report Number
    1911916-2024-00802
    Event Type
    Malfunction
    Date Received
    November 11, 2024
    Date of Event
    October 18, 2024
    Report Date
    November 19, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    50382903010313
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR 11013088 FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THE SYRINGES HAD MISSING PRINT. TO AID IN THE INVESTIGATION, FIVE SAMPLES WITH NO PACKAGING AND ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. THE 'BD' LOGO ON THE SYRINGE HAS A PARTIALLY PRINTED 'D.' THE PHOTO PROVIDED SHOWS ONE OF THE SAMPLES RECEIVED. THE SYMPTOM REPORTED IS CONSIDERED AN ACCEPTABLE IMPERFECTION. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301031, LOTS 4172588 AND 4172585. 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. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED, BUT ACCEPTABLE.

    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 BATCH PROVIDED: BATCH: 4172588 BATCH CREATION DATE: 2024-06-20 BATCH EXPIRATION DATE: 2029-06-30 FULL UDI: (B)(4).

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED

    Description of Event or Problem · 0

    MATERIAL#: 301031 BATCH#: 4172588 & 4172585. IT WAS REPORTED BY THE CUSTOMER THAT SYRINGES MISSING PRINT. RCC RECEIVED A COMPLAINT VIA EMAIL. COMPLAINT NUMBER: (B)(4). ACCOUNT NAME: CONTACT PERSON: ITEM NUMBER: B-D301031 ITEM DESCRIPTION: SYRINGE, LL, 20 ML, NON-STERILE. INCIDENT DESCRIPTION: SYRINGES MISSING PRINT. ITEM: 301031. QUANTITY AFFECTED:33EA SERIAL/LOT NUMBER: (B)(6). PO: (B)(6). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES REPORTED ISSUE: DURING PROCESS IN PRODUCTION, IT WAS FOUND SYRINGES MISSING PRINT. CUSTOMER DISPOSITION REQUEST: CREDIT MEDLINE, CUSTOMER REQUESTING FORM LETTER ON FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890353 SYRINGE 20ML LL BNS SYRINGE, PISTON FMF BECTON DICKINSON 4172585 50382903010313

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown