BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML LS SP120

    MDR report key: 12437313 · Received September 8, 2021

    Report

    Report Number
    3003152976-2021-00569
    Event Type
    Malfunction
    Date Received
    September 8, 2021
    Date of Event
    June 30, 2021
    Report Date
    October 5, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: PHOTOS AND TWO SYRINGES INSIDE THEIR ORIGINAL PACKAGING, NOT USED AND CLOSED RECEIVED FOR INVESTIGATION, UPON VISUAL INSPECTION OF THE SAMPLE PROVIDED FROM LOT 2010080 IT CAN BE OBSERVED A HAIR ACROSS THE TWO BLISTERS OF THE DEVICES. THIS SUGGEST, THE HAIR FELL DURING PACKAGING PROCESS, AS IT IS LOCATED BETWEEN FILM AND PAPER OF BOTH UNITARY PACKAGING. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2010080, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED 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. 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. POSSIBLE ROOT CAUSE IS HUMAN ERROR, IT LIKELY GENERATED DURING THE PACKAGING PROCESS DUE TO OPERATORS NOT FOLLOWING PROPER CLOTHING PROTOCOL. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT TO INCREASE AWARENESS OF THIS MATTER. A PROJECT WAS INITIATED TO REDUCE ANY FOREIGN MATTER INSIDE OUR PRODUCTS. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 SYRINGE 1ML LS SP120 PACKAGING UNITS HAD HAIR IN THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH; "THE CUSTOMER USES THIS PRODUCT FOR COVID-19 VACCINATION. THE CUSTOMER REPORTED THAT HAIR WAS FOUND IN PACKAGE."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 SYRINGE 1ML LS SP120 PACKAGING UNITS HAD HAIR IN THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH; "THE CUSTOMER USES THIS PRODUCT FOR COVID-19 VACCINATION. THE CUSTOMER REPORTED THAT HAIR WAS FOUND IN PACKAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1335118 SYRINGE 1ML LS SP120 PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2010080

    Patients

    Seq Age Sex Outcome Treatment
    1