BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 1ML LS 27GA 1/2IN

    MDR report key: 20155870 · Received September 6, 2024

    Report

    Report Number
    9614033-2024-00058
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Date of Event
    August 16, 2024
    Report Date
    September 26, 2024
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    07501073024854
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    PHOTOS AND SAMPLES RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, OUR INVESTIGATION TEAM WAS ABLE TO OBSERVE BLACK DOTS ON THE BODY OF THE SYRINGE. THE REPORTED NONCONFORMANCE HAS BEEN CONFIRMED. ADDITIONALLY, THE BLACK DOTS WERE ABLE TO BE REMOVED FROM THE CYLINDER BUT WERE NOT SUFFICIENT IN QUANTITY OR MATERIAL TO SUBMIT FOR COMPOSITIONAL TESTING. THE IDENTITY OF THE FOREIGN BODY COULD NOT BE DETERMINED AT THE CONCLUSION OF OUR REVIEW. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED AND ADDITIONAL TRAINING TO REINFORCE PROPER ASSEMBLY HAS BEEN PERFORMED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 1ML LS 27GA 1/2IN HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM SPANISH TO ENGLISH: (B)(6) PIECES OF SYRINGE WERE RECEIVED. DURING THE INSPECTION, (B)(6) PIECES OF SYRINGE/ 1 ML WERE DETECTED WITH APPARENT PRESENCE OF FOREIGN PARTICLES IN THE CONTENT OF THE PRODUCT. DEFECTIVE CLASSIFIED AS CRITICAL, REJECTING THE PIECES RECEIVED. ATTACHED INSPECTION REPORT. MATERIAL: 1012405 PRESENTATION: SYRINGE 1 ML PLASTIPAK C/A TUBERC 25X 16 LOT: 3003262 EXPIRATION: 11/2027 ADDITIONAL INFORMATION RECEIVED WOULD YOU BE SO KIND AS TO CONFIRM IF ALL (B)(6) UNITS WERE IDENTIFIED IN THE SAME BOX? -WE RECEIVED (B)(6) UNITS OF WHICH 1704 WERE APPROVED. EACH COLLECTIVE PACKAGE CONTAINED 100 SYRINGES RECEIVING A TOTAL OF (B)(6) BOXES OF WHICH 696 OF THE REJECTED UNITS WERE IDENTIFIED IN DIFFERENT COLLECTIVE PACKAGES. 696 OF THE REJECTED UNITS WERE IDENTIFIED IN DIFFERENT COLLECTIVE PACKAGES. ARE SAMPLES RELATED TO THE INCIDENT AVAILABLE FOR ANALYSIS? IF YES, PLEASE INDICATE THE QUANTITY. -THE TOTAL NUMBER OF REJECTED PIECES IS AVAILABLE. ADDITIONAL INFORMATION RECEIVED FOR SAMPLE COLLECTION, PLEASE INFORM - CUSTOMER SHARED THE INFORMATION AND ADDED IT AS ATTACHMENTS - COULD YOU PLEASE SHARE THE INSPECTION REPORT MENTIONED IN THE EMAIL? - CUSTOMER HAS SHARED THE FORM AND ADDED THE ATTACHMENTS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2042516 BD SYRINGE 1ML LS 27GA 1/2IN PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 3003262 07501073024854

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown