BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE

    MDR report key: 10732300 · Received October 26, 2020

    Report

    Report Number
    3002682307-2020-00322
    Event Type
    Malfunction
    Date Received
    October 26, 2020
    Date of Event
    July 13, 2020
    Report Date
    November 2, 2020
    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

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 1902194 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. AS SAMPLES WERE UNAVAILABLE FOR RETURN, OUR QUALITY TEAM OBTAINED TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER FROM THE MANUFACTURING FACILITY FOR FURTHER EVALUATION. THE RETAINED SAMPLES WERE EXAMINED AND NO DEFECTS WERE OBSERVED. BASED ON THE PROVIDED CUSTOMER FEEDBACK, IT IS POSSIBLE THAT THE PARTICLES DESCRIBED ARE RELATED TO A LUBRICANT ACCUMULATION IN THE BODY OF THE SYRINGE. THE LUBRICANT PARTICLES ARE INHERENT TO THE SYRINGE BARREL COMPOSITION AND ARE OF NO DANGER TO PATIENT HEALTH. WITH THE HIGH-VOLUME MANUFACTURING PROCESS, IT IS POSSIBLE THAT SOME PARTICULATE MATTER MAY BE GENERATED; HOWEVER, THROUGH THE STRINGENT PROCESSES AND ENVIRONMENTAL CONTROLS IN PLACE, PARTICULATE MATTER IS KEPT AT EXTREMELY LOW LEVELS WITHIN THE MANUFACTURING FACILITY. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE IDENTIFIED FOR THIS REPORTED INCIDENT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CLEAR, CORD-SHAPED PIECE OF FOREIGN MATTER WAS FOUND IN THE BD¿ SYRINGE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "IT WAS FOUND THAT THERE WAS A CLEAR CORD-SHAPED FOREIGN MATTER IN THE SYRINGE CHAMBER, THE SYRINGE AND DRUG WERE IMMEDIATELY REPLACED AND THEN INTRAMUSCULAR INJECTION WAS GIVEN TO THE PATIENT".

    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 A CLEAR, CORD-SHAPED PIECE OF FOREIGN MATTER WAS FOUND IN THE BD¿ SYRINGE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "IT WAS FOUND THAT THERE WAS A CLEAR CORD-SHAPED FOREIGN MATTER IN THE SYRINGE CHAMBER, THE SYRINGE AND DRUG WERE IMMEDIATELY REPLACED AND THEN INTRAMUSCULAR INJECTION WAS GIVEN TO THE PATIENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203284 BD SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1902194

    Patients

    Seq Age Sex Outcome Treatment
    1