BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 23627637 · Received November 23, 2025

    Report

    Report Number
    1911916-2025-00760
    Event Type
    Malfunction
    Date Received
    November 23, 2025
    Date of Event
    October 30, 2025
    Report Date
    December 15, 2025
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903096534
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP. IT WAS REPORTED THE SYRINGE TIP EXPLODED DURING USE. OUR QUALITY TEAM HAS COMPLETED A DEVICE HISTORY RECORD REVIEW FOR MATERIAL NUMBER 309653 AND LOT NUMBER 5142417. THE REVIEW DID NOT IDENTIFY ANY ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE DEFECT, AND ALL QUALITY TESTS WERE WITHIN SPECIFICATION. DUE TO THE UNAVAILABILITY OF A SAMPLE FOR RETURN, A COMPREHENSIVE SAMPLE INVESTIGATION COULD NOT BE CONDUCTED. CONSEQUENTLY, THE EXACT CAUSE OF THIS INCIDENT REMAINS UNDETERMINED. SHOULD YOU ENCOUNTER ANY FURTHER ISSUES WITH OUR PRODUCT, WE WOULD APPRECIATE THE OPPORTUNITY TO PERFORM A DETAILED ANALYSIS. AT THIS TIME, NO FURTHER ACTION IS DEEMED NECESSARY.

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THAT THE SYRINGE TIP EXPLODED DURING USE. TO SUPPORT THE INVESTIGATION, ONE SAMPLE WITHOUT ITS PACKAGING BLISTER WAS RECEIVED FOR EVALUATION BY THE QUALITY TEAM. A VISUAL INSPECTION REVEALED THAT THE BOTTOM PORTION OF THE SYRINGE BARREL WAS DAMAGED AND MISSING. NO ADDITIONAL DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS CONDITION MAY OCCUR IF A JAM OCCURS DURING THE ASSEMBLY PROCESS. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED FOR MATERIAL NUMBER 309653, LOT 5142417. THE REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE FOUND. ALL PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. VERIFICATION OF THE ASSEMBLY PROCESS CONFIRMED THAT THE RAILS AND CONVEYORS WERE PROPERLY ALIGNED AND THAT PRODUCT FLOW WAS CONSISTENT. BASED ON THE INVESTIGATION AND ANALYSIS OF THE RETURNED SAMPLE, THE SYMPTOM REPORTED BY THE CUSTOMER HAS BEEN CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 50ML LL TIP 1ML HAD TIP BREAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #309653. BATCH #5142417. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I WAS ASKED TO PASS ALONG A SAFETY ISSUE THAT WAS REPORTED BY @XXX, CC'D IN THIS EMAIL. PLEASE SEE DETAILS OF THE REPORT BELOW: ¿EVENT: DURING PERICARDIOCENTESIS, 50 ML SYRINGE WAS BEING USED TO PULL DRAINAGE FROM PERICARDIAL SPACE. SYRINGE TIP EXPLODED, CAUSING BLOOD TO SPATTER ALL AROUND THE PATIENT. PIECES OF PLASTIC FROM THE SYRINGE WERE ALSO SENT AROUND FROM THE FORCE. PATIENT AND STAFF WERE UNHARMED.¿ PRODUCT: BD 50 ML SYRINGE LUER-LOK TIP, P#309653. LOT: 5142417. DATE OF INCIDENT: (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2749137 BD LUER-LOK PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 5142417 00382903096534

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown