BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE PLASTIPAK 10ML S/SU

    MDR report key: 20220919 · Received September 15, 2024

    Report

    Report Number
    3003916417-2024-00214
    Event Type
    Malfunction
    Date Received
    September 15, 2024
    Date of Event
    August 26, 2024
    Report Date
    October 10, 2024
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    UDI-DI
    07891463000378
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHOTO RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A HAIR WAS OBSERVED INSIDE THE BLISTER PACK, THEREFORE THE INCIDENT IS CONFIRMED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 4170620, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. MANUFACTURING FOR THIS PRODUCT IS PERFORMED IN A CLEAN ROOM WHICH IS KEPT UNDER A POSITIVE PRESSURE TO REDUCE THE CHANCE OF FOREIGN MATTER. 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. ALL INDIVIDUALS ARE REQUIRED TO FOLLOW PROPER GOWNING PROCEDURES BEFORE ENTERING THE ROOM, INCLUDING HAIR PROTECTION. THE ROOT CAUSE OF THIS INCIDENT IS DUE TO PERSONNEL NOT FOLLOWING THE PROPER GOWNING PROCEDURE. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT TO INCREASE AWARENESS OF THIS MATTER.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE PLASTIPAK 10ML S/SU HAS FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM PORTUGUESE TO ENGLISH: HAIR FOUND INSIDE THE SEALED PACKAGING OF THE 10ML LUER-LOCK SYRINGE 990172. OCCURRENCE HAPPENED BEFORE USE. CUSTOMER INFORMS THAT HE RECEIVED A NOTIFICATION YESTERDAY (26/08/24) ABOUT A QUALITY DEVIATION IN A 990172 SYRINGE PACKAGE WITH HAIR INSIDE. QUANTITY: (B)(4) UNIT. AVAILABLE FOR COLLECTION. DEVIATION: STRAND OF HAIR INSIDE THE SYRINGE WITH SEALED PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101748 BD SYRINGE PLASTIPAK 10ML S/SU PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 4170620 07891463000378

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown