BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL SP125

    MDR report key: 22690478 · Received August 1, 2025

    Report

    Report Number
    1213809-2025-00512
    Event Type
    Malfunction
    Date Received
    August 1, 2025
    Date of Event
    July 16, 2025
    Report Date
    September 26, 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)(4) - SUPPLEMENTAL MDR - PACKAGE DAMAGED / DEFECTIVE / OTHER. A TOTAL OF NINETY-SIX SAMPLES AND FOUR SUPPORTING PHOTOGRAPHS OF 5ML LUER-LOK SYRINGES (PART NUMBER 309646), BATCH 5112799, WERE EVALUATED. TWO SAMPLES WERE FOUND TO BE FREE OF DEFECTS AND DEEMED ACCEPTABLE. THE REMAINING NINETY-FOUR SAMPLES WERE RECEIVED IN UNSEALED PACKAGES, EACH EXHIBITING AN OPEN SEAL WITH GRID ALONG THE SHORT SEAL ON THE PEEL TAB, AS CONFIRMED BY PHOTOGRAPHIC EVIDENCE. 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 PROVIDED LOT NUMBER 5112799. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE 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 ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    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 FOR DEVICE EVALUATION. NINETY-SIX SAMPLES AND FOUR SUPPORTING PHOTOS OF 5ML LUER-LOK SYRINGES (PART NUMBER 309646, BATCH 5112799) WERE RECEIVED AND EVALUATED. ALL SAMPLES EXHIBITED AN OPEN SEAL WITH GRID MARKS ALONG THE ENTIRE LENGTH OF THE SHORT SEAL ON THE PEEL TAB, INDICATING A PACKAGING INTEGRITY ISSUE. THE SUBMITTED PHOTOS INCLUDED VARIABLE DATA ON THE TOP WEB, A CLEAR BAG CONTAINING ALL SYRINGES, AND TWO IMAGES CLEARLY SHOWING THE OPEN SEAL CONDITION. THE OBSERVED CONDITION IS NON-CONFORMING PER PRODUCT SPECIFICATIONS. THE POTENTIAL ROOT CAUSE OF THE OPEN SEAL DEFECT IS ASSOCIATED WITH THE PACKAGING PROCESS. THIS ISSUE WAS IDENTIFIED DURING PRODUCTION OF THE BATCH, PROMPTING A REQUALIFICATION AND LINE CLEARANCE. HOWEVER, IT IS POSSIBLE THAT A LIMITED NUMBER OF DEFECTIVE UNITS ESCAPED DETECTION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 5ML LL SP125 PACKAGING WAS DAMAGED / DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #309646 LOT #5112799. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. JUST EMAILING TO MAKE LOGISTICS AWARE THAT AT IN WE HAVE PULLED A LARGE NUMBER OF 5 CC SYRINGES FROM OUR CORES THAT THE PACKAGING HAS NOT BEEN SEALED CORRECTLY. PLEASE SEE ATTACHED PICTURES. AFFECTED LOT NUMBER: 5112799.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1184579 BD SYRINGE 5ML LL SP125 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5112799

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown