BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK STERILE LUER SLIP 1ML SYRINGES W/OUT NEEDLE

    MDR report key: 12200573 · Received July 20, 2021

    Report

    Report Number
    3003152976-2021-00408
    Event Type
    Malfunction
    Date Received
    July 20, 2021
    Date of Event
    June 22, 2021
    Report Date
    September 28, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    K182589
    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 RECEIVED FOR INVESTIGATION, THROUGH VISUAL INSPECTION NO SCALE MARKING DEFECTS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW FOR LOT 2011076 SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. ADDITIONALLY, TEN RETAINED SAMPLES FROM THE SAME LOT WERE EVALUATED, VOLUME AND SCALE MARKING ACCURACY WERE PERFORMED AND FOUND TO BE WITHIN REQUIRED SPECIFICATIONS. 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. SINCE MANUFACTURING RECORD STABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY, AND TESTS PERFORMED WITH RETAINED SAMPLES ARE WITHIN SPECIFICATION LIMITS, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCALE MARKINGS ARE MISSING WITH A BD PLASTIPAK¿ STERILE LUER SLIP 1ML SYRINGES W/OUT NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A REPORT ABOUT A SCALE MARKING ISSUE OF SYRINGE. ACCORDING TO THE CUSTOMER'S REPORT, SCALE MARKING POSITIONS SEEM TO BE DEFECTIVE AND VARY AMONG SYRINGES.

    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 THE SCALE MARKINGS ARE MISSING WITH A BD PLASTIPAK¿ STERILE LUER SLIP 1ML SYRINGES W/OUT NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THIS IS A REPORT ABOUT A SCALE MARKING ISSUE OF SYRINGE. ACCORDING TO THE CUSTOMER'S REPORT, SCALE MARKING POSITIONS SEEM TO BE DEFECTIVE AND VARY AMONG SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094149 BD PLASTIPAK STERILE LUER SLIP 1ML SYRINGES W/OUT NEEDLE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2011076

    Patients

    Seq Age Sex Outcome Treatment
    1