BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK

    MDR report key: 21758484 · Received April 2, 2025

    Report

    Report Number
    1213809-2025-00229
    Event Type
    Malfunction
    Date Received
    April 2, 2025
    Date of Event
    March 6, 2025
    Report Date
    April 14, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096054
    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

    (B)(4) - SUPPLEMENTAL MDR - FOREIGN MATTER. IT WAS REPORTED THERE WAS DISCOLORATION IN THE SYRINGE TIP. TWO SAMPLES FROM BATCH 4192357 AND FOUR PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS WERE OBSERVED ON THE RECEIVED SAMPLES. ALL FOUR PHOTOS ARE EXTREME CLOSE-UP IMAGES. ONE PHOTO SHOWS AN UNKNOWN WHITE SPOT ON THE STOPPER. THE SECOND PHOTO SHOWS ONE TAN SPOT ON THE STOPPER. THE THIRD PHOTO SHOWS A BROWN DISCOLORATION IN THE BARREL CONSISTENT WITH EMBEDDED FOREIGN MATTER. THE LAST PHOTO SHOWS A BLACK SPOT IN THE BARREL CONSISTENT WITH EMBEDDED FOREIGN MATTER. THE CONDITIONS OBSERVED ARE NON-CONFORMING PER PRODUCT SPECIFICATION. THE ROOT CAUSE FOR THE EMBEDDED FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. THE EMBEDDED FOREIGN MATTER IS MOST LIKELY DEGRADED PLASTIC. THIS OCCURS WHEN THE RESIN IS EXPOSED TO PROLONGED HIGH TEMPERATURES INSIDE THE MOLDING MACHINE, SUCH AS DURING START-UP. THIS TYPE OF DEFECT IS COSMETIC AND DOES NOT POSE A RISK TO THE CUSTOMER. THE ROOT CAUSE FOR THE FOREIGN MATTER IN FLUID PATH IS ASSOCIATED WITH THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 4192357. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 4192357 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITIONS 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

    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 WAS PROVIDED.

    Description of Event or Problem · 0

    MATERIAL # 309605 LOT # 4192357   IT WAS REPORTED THAT THE BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED HELLO, PLEASE SEE THE ATTACHED IMAGE(S) AND DETAILS OF REPORTED DEFECTIVE MATERIAL: DMR # 450 PO #: NJ00010362 DEFECT MATERIAL DESCRIPTION: SYRINGE TRAY, 10ML BD 20PK (REF. 309605) LOT NUMBER: 4192357 ITEM CODE: 309605 DEFECTIVE QUANTITY: (B)(4). DEFECT DESCRIPTION: DISCOLORATION IN SYRINGE TIP OF RETENTION SAMPLES AND CUSTOMER UNITS ON BD 10 ML SYRINGE LOT 4192357. OBSERVED DATE: MARCH 6, 2025 OBSERVED DURING WHICH PROCESS STAGE: MARKET IR/ DMI NUMBER IF LAUNCHED: DEV-3210 SAMPLE AVAILABILITY FOR SUPPLIER TO INVESTIGATE: YES IS DEFECTIVE EVIDENCE (I.E. PICTURES; TEST RESULTS ETC.) AVAILABLE? YES IS PATIENT IMPACTED? NO IF DEFECT HAS BEEN REPORTED TO THIRD PARTY? NO IF THE DEFECT REPORT FROM QUVA CUSTOMER? NO IS THERE A TREND OBSERVED? NO. SUPPLIER ACTION INVESTIGATION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614603 BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4192357 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown