BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 24778437 · Received April 3, 2026

    Report

    Report Number
    9614033-2026-00021
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    February 23, 2026
    Report Date
    April 24, 2026
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THREE PHOTOS WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. A CRACK WAS OBSERVED ON THE WALL OF THE BARREL; THEREFORE, THE REPORTED INCIDENT COULD BE VERIFIED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE IS RELATED TO MANUFACTURING. A PROJECT HAS BEEN STARTED TO FURTHER INVESTIGATE THE PROCESS. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 10 ML LL BNS BARREL CRACKED. COMPLAINT VIA EMAIL: WE WERE NOTIFIED OF A COMPLAINT FROM A CUSTOMER STATING SYRINGES CRACKED. PLEASE SEE THE BELOW DETAILS REGARDING THE REPORTED ISSUE. IF IT IS INDICATED THAT A SAMPLE IS AVAILABLE, PLEASE PROVIDE SHIPPING INSTRUCTIONS WITHIN 30 DAYS OR THE SAMPLE WILL BE DISPOSED OF. COMPLAINT #: (B)(4). DEFECT DESCRIPTION: SYRINGES CRACKED. PART #: 153239, PRODUCT DESCRIPTION: SYRINGE 10 ML LL BNS, VENDOR PART #: 304657, LOT #: 5069256. DATE REPORTED: 2/26/2026. SAMPLE RECEIVED: NO - BIOHAZARDOUS RESPONSE NEEDED: YES - INCIDENT REPORTED TO THE FDA AS MDR-30 DAY. REFERENCE NO. 1423395-2026-00044 PLEASE REFERENCE THE ABOVE COMPLAINT NUMBER IN ALL FUTURE COMMUNICATIONS. IF YOU HAVE QUESTIONS OR NEED ADDITIONAL INFORMATION, PLEASE REACH OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289281 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 5069256

    Patients

    Seq Age Sex Outcome Treatment
    1