BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL SP125

    MDR report key: 22834990 · Received August 18, 2025

    Report

    Report Number
    1213809-2025-00550
    Event Type
    Malfunction
    Date Received
    August 18, 2025
    Date of Event
    August 1, 2025
    Report Date
    October 2, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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) - SUPPLEMENTAL MDR - PACKAGE DAMAGED / DEFECTIVE / OTHER. A TOTAL OF FORTY-TWO SAMPLES OF 5ML LUER-LOK SYRINGES (PART NUMBER 309646) WERE RECEIVED AND EVALUATED. THESE INCLUDED (B)(4) SAMPLES FROM BATCH 5132909, (B)(4) SAMPLES EACH FROM BATCHES 5023089 AND 5029101, (B)(4) SAMPLES FROM BATCH 5069390, AND (B)(4) SAMPLE FROM BATCH 5029100. ALL SAMPLES EXHIBITED AN OPEN SEAL WITH A GRID ALONG THE ENTIRE LENGTH OF THE SHORT SEAL ON THE PEEL TAB. INTERVIEWS WITH PROCESS ENGINEERS, A PROJECT ENGINEER SPECIALIZING IN RAW MATERIALS, AND A QUALITY ENGINEER DID NOT IDENTIFY THE PACKAGING PROCESS OR RAW MATERIALS AS CONTRIBUTING FACTORS. AS THE CONDITION COULD NOT BE TRACED TO THE MANUFACTURING SITE, NO CORRECTIVE ACTIONS ARE NECESSARY. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR LOT NUMBERS 5132909, 5029100, 5069390, 5029101, AND 5023089. THE REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED IN TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA TO IDENTIFY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 5ML LL SP125 PACKAGE WAS DAMAGED / DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 309646 BATCH#: 5132909, 5029100, 5069390, 5029101, 5023089. IT WAS REPORTED BY THE CUSTOMER THAT THE PACKAGING HAS NOT BEEN SEALED CORRECTLY. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE RECEIVED SAMPLES FOR THIS COMPLAINT. THERE WERE ALSO SEVERAL ADDITIONAL LOTS INCLUDED. MANY OF THESE ADDITIONAL LOTS DID SEEM TO SHOW THE SAME ISSUE AS THE REPORTED ONE. SEE BELOW. 138 SAMPLE(S) RECEIVED AND NOT DECONTAMINATED IN XXXXXXX. MAT# 309646. LOT#. GRID-5112799. PACKAGES. 5112799-QTY 96. 5132909-QTY 33. 5029100-QTY 1. 5069390-QTY 2. 5029101-QTY 3. 5023089-QTY 3. SAMPLE(S) SENT TO XXXX LAB PENDING FURTHER INSTRUCTIONS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1680544 BD SYRINGE 5ML LL SP125 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5029101

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown