BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML LS 26X1/2IN INDIA

    MDR report key: 10300071 · Received July 20, 2020

    Report

    Report Number
    8041187-2020-00418
    Event Type
    Malfunction
    Date Received
    July 20, 2020
    Date of Event
    June 30, 2020
    Report Date
    October 15, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: FOUR PHOTOS WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FOREIGN MATTER WAS OBSERVED INSIDE THE PACKAGING IN THE RETURNED PHOTOS. THEREFORE, THE TEAM WAS ABLE TO CONFIRM THE CUSTOMER EXPERIENCE. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. ALTHOUGH TEAM WAS ABLE TO OBSERVE THE FOREIGN MATTER NONCONFORMANCE, THERE WERE NO PHYSICAL SAMPLES RETURNED TO DETERMINE THE FOREIGN MATTER TYPE. THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1,400 SYRINGE 1ML LS 26X1/2IN INDIA EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLACK PARTICLES ARE SEEN IN SIDE THE SYRINGE. FLOW OF MATERIAL IS FROM DISTRIBUTOR TO THE HOSPITAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1,400 SYRINGE 1ML LS 26X1/2IN INDIA EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLACK PARTICLES ARE SEEN IN SIDE THE SYRINGE. FLOW OF MATERIAL IS FROM DISTRIBUTOR TO THE HOSPITAL.

    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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8211176. MEDICAL DEVICE EXPIRATION DATE: 2023-07-31. DEVICE MANUFACTURE DATE: 2018-07-30. MEDICAL DEVICE LOT #: 9326987. MEDICAL DEVICE EXPIRATION DATE: 2024-11-30. DEVICE MANUFACTURE DATE: 2019-11-22. MEDICAL DEVICE LOT #: 8332781. MEDICAL DEVICE EXPIRATION DATE: 2023-11-30. DEVICE MANUFACTURE DATE: 2018-11-28. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 1,400 SYRINGE 1ML LS 26X1/2IN INDIA EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLACK PARTICLES ARE SEEN IN SIDE THE SYRINGE. FLOW OF MATERIAL IS FROM DISTRIBUTOR TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764203 SYRINGE 1ML LS 26X1/2IN INDIA SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other