BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE

    MDR report key: 11143720 · Received January 9, 2021

    Report

    Report Number
    3002682307-2021-00004
    Event Type
    Malfunction
    Date Received
    January 9, 2021
    Date of Event
    November 27, 2020
    Report Date
    April 19, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 1/13/2021. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1904152. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, TWO SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLES, NO SIGNS OF LEAKAGE WERE OBSERVED. TO FURTHER EVALUATE THIS ISSUE, TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY. THE RETAINED SAMPLES WERE EXAMINED AND NO SIGNS OF DEFECT WERE IDENTIFIED. BASED ON THE PROVIDED FEEDBACK, IT IS POSSIBLE THAT THIS REPORTED INCIDENT RESULTED FROM AN INEFFECTIVE LUER SLIP FITTING BETWEEN THE NEEDLE AND THE SYRINGE TIP. THIS COULD BE CAUSED BY A DEFECTIVE LUER DIMENSION OR A DAMAGE PRODUCT; HOWEVER, BASED ON THE SAMPLE ANALYSIS FINDINGS, THE EXACT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD¿ SYRINGES LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "SYRINGE IS POOR AIRTIGHTNESS AND LEAKED."

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD¿ SYRINGES LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "SYRINGE IS POOR AIRTIGHTNESS AND LEAKED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40458 BD SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1904152

    Patients

    Seq Age Sex Outcome Treatment
    1