BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL NS

    MDR report key: 18410277 · Received December 28, 2023

    Report

    Report Number
    3003152976-2023-00556
    Event Type
    Malfunction
    Date Received
    December 28, 2023
    Date of Event
    December 19, 2023
    Report Date
    June 10, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    50382903020558
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR(B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP MDR FOR UPDATED DEVICE EVALUATION (PHYSICAL SAMPLE RETURNED): ONE SAMPLE AND TWO PHOTOS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, FOREIGN MATTER CAN BE OBSERVED WITHIN THE SYRINGE. THE PARTICLE IS BROWN IN COLOR AND APPEARS GREASY. CHARACTERIZATION TESTING WAS PERFORMED TO IDENTIFY THE COMPOSITION, UNFORTUNATELY, THE RESULTS OF THIS TESTING WERE INCONCLUSIVE. BASED ON THE PHYSICAL APPEARANCE, THE PARTICLE APPEARS TO BE DIRT MIXED WITH POLYPROPYLENE, HOWEVER, IT CANNOT BE DEFINITIVELY IDENTIFIED AT THIS TIME. MANUFACTURING FOR THIS PRODUCT IS PERFORMED IN A CLEAN ROOM WHICH IS KEPT UNDER A POSITIVE PRESSURE TO REDUCE THE CHANCE OF FOREIGN MATTER. THE ASSEMBLY STATION HAS A DE-IONIZER AND VACUUM SYSTEM USED TO REMOVE ANY PARTICLES INSIDE THE BARREL. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2212037, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. THE AREAS WHERE PIECES RUN IN MANUFACTURING AREA ARE PROTECTED TO REDUCE PARTICLES FROM GENERATING AND MANUFACTURING EQUIPMENT UNDERGOES ROUTINE CLEANING AND MAINTENANCE. WHILE WE CANNOT IDENTIFY A DIRECT ISSUE, THE PARTICLE LIKELY GENERATED DURING THE MOLDING OR ASSEMBLY PROCESS. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT TO INCREASE AWARENESS OF THIS MATTER. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: PHOTOS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, FOREIGN MATTER CAN BE OBSERVED IN THE FLUID PATH OF THE SYRINGE. PHYSICAL SAMPLES ARE REQUIRED TO FURTHER ANALYZE AND IDENTIFY THE FOREIGN MATTER. MANUFACTURING FOR THIS PRODUCT IS PERFORMED IN A CLEAN ROOM WHICH IS KEPT UNDER A POSITIVE PRESSURE TO REDUCE THE CHANCE OF FOREIGN MATTER. THE ASSEMBLY STATION HAS A DE-IONIZER AND VACUUM SYSTEM USED TO REMOVE ANY PARTICLES INSIDE THE BARREL. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. THE AREAS WHERE PIECES RUN IN MANUFACTURING AREA ARE PROTECTED TO AVOID DAMAGE ON THE PRODUCT AND REDUCE PARTICLES FROM GENERATING. WHILE WE CANNOT IDENTIFY A DIRECT ISSUE, THE PARTICLE LIKELY GENERATED DURING THE MANUFACTURING PROCESS DUE TO CONTAMINATION. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT TO INCREASE AWARENESS OF THIS MATTER.

    Description of Event or Problem · 0

    WE HAVE RECEIVED A COMPLAINT FROM OUR CUSTOMER FOR THE FOLLOWING PRODUCT: ITEM NUMBER PROMEDICAL: 171150. DESCRIPTION GERMAN: SYRINGE 20ML LUER-LOCK, NON-STERILE. ITEM NUMBER BD BECON DICKINSON AG: 302055. LOT NUMBER : 2212037. SUPPLIER / SUPPLIER NUMBER : BD BECTON DICKINSON AG / 173. COMPLAINT QUANTITY: (B)(4). CATEGORY OF COMPLAINT: (B)(4). REASON FOR COMPLAINT: SYRINGE HAS BROWN-BLACK RESIDUE AT THE BASE OF THE HOLLOW BODY, IN THE AREA OF THE LIQUID OUTLET (PHOTO ATTACHED). REQUIREMENTS: REPORT (E.G. 8D / CAPA) INCLUDING: INVESTIGATION. ROOT CAUSE. POTENTIALLY AFFECTED PRODUCTS/LOTS. IMMEDIATE ACTIONS. REMEDIAL ACTIONS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400330 SYRINGE 20ML LL NS SYRINGE, PISTON FMF BECTON DICKINSON 2212037 50382903020558

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown