BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 1ML LL BNS

    MDR report key: 19996781 · Received August 15, 2024

    Report

    Report Number
    1213809-2024-00547
    Event Type
    Malfunction
    Date Received
    August 15, 2024
    Date of Event
    October 10, 2023
    Report Date
    August 9, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    50382903096485
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.4. OTHER LOT NUMBER INCLUDES 3131805 AND OTHER EXPIRATION DATE INCLUDES 2028-04-30. H.4. OTHER LOT NUMBER DEVICE MANUFACTURE DATE IS 2023-05-11. DEVICE EVALUATION: ONE HUNDRED LOOSE SAMPLES AND THREE PHOTOS OF 1ML LUER-LOK SYRINGES WERE RECEIVED BY BD. A QUALITY ENGINEER WAS ABLE TO EXAMINE THE SAMPLES AND PHOTOS FROM BATCH 3131805/3165195 REGARDING ITEM 309648. THROUGH VISUAL INSPECTION, IT WAS OBSERVED THAT TWO SAMPLES HAD DISTORTED/JAMMED STOPPER, THIRTY-ONE SAMPLES HAD PLUNGER ROD BROKEN OFF FROM THE STOPPER INSIDE THE BARREL, FOUR SAMPLES WERE MISSING PLUNGER ROD WITH STOPPER AND SIXTY-EIGHT SAMPLE WERE OBSERVED TO HAVE LOOSE BROKEN PLUNGER RODS. THE CONDITIONS OBSERVED ARE NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE PLUNGER ROD MISSING, STOPPER DISTORTED, AND PLUNGER ROD BROKEN DEFECT ARE ASSOCIATED WITH THE ASSEMBLY PROCESS. THESE DEFECTS ARE OCCURRING BELOW AN EXPECTED RATE SO NO CORRECTIVE ACTIONS WILL BE MADE AT THIS TIME. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 3131805. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 1ML LL BNS PLUNGER ROD WAS BROKEN/DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM DUTCH TO ENGLISH: WHEN PROCESSING BATCH 3116819 (5ML), 100 SYRINGES WITHOUT PLUNGERS WERE FOUND. WHEN PROCESSING BATCHES 3131805 AND 3165195 (1 ML), A SIMILAR INCIDENT WAS ESCALATED THAT SYRINGES WITHOUT PLUNGERS WERE FOUND. ALCON COMPLAINT PR#(B)(4) AND BD COMPLAINT PR#(B)(4) WERE INDEED INITIATED. THE SAMPLES YOU RECEIVED SHOULD BE FOR BOTH INCIDENTS REGARDING 1 ML AND 5 ML SYRINGES WITHOUT PLUNGERS. CAN YOU SEND SOME PICTURES OF THE 5ML SYRINGES? THERE MIGHT HAVE BEEN A MIX-UP WITH ANOTHER COMPLAINT THAT WAS RAISED BY ALCON (BD COMPLAINT PR#(B)(4) FOR WHICH SYRINGES WITH BAD PRINTING OF VOLUMETRIC SCALE WERE OBSERVED. AS PER INVESTIGATION: ONE HUNDRED LOOSE SAMPLES AND THREE PHOTOS OF 1ML LUER-LOK SYRINGES WERE RECEIVED BY BD. A QUALITY ENGINEER WAS ABLE TO EXAMINE THE SAMPLES AND PHOTOS FROM BATCH 3131805/3165195 REGARDING ITEM 309648. THROUGH VISUAL INSPECTION, IT WAS OBSERVED THAT TWO SAMPLES HAD DISTORTED/JAMMED STOPPER, THIRTY-ONE SAMPLES HAD PLUNGER ROD BROKEN OFF FROM THE STOPPER INSIDE THE BARREL, FOUR SAMPLES WERE MISSING PLUNGER ROD WITH STOPPER AND SIXTY-EIGHT SAMPLE WERE OBSERVED TO HAVE LOOSE BROKEN PLUNGER RODS. THE CONDITIONS OBSERVED ARE NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE PLUNGER ROD MISSING, STOPPER DISTORTED, AND PLUNGER ROD BROKEN DEFECT ARE ASSOCIATED WITH THE ASSEMBLY PROCESS. THESE DEFECTS ARE OCCURRING BELOW AN EXPECTED RATE SO NO CORRECTIVE ACTIONS WILL BE MADE AT THIS TIME. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 3131805. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151910 BD SYRINGE 1ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3165195 50382903096485

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown