BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿10ML SYRINGE

    MDR report key: 17803530 · Received September 22, 2023

    Report

    Report Number
    8041187-2023-00500
    Event Type
    Malfunction
    Date Received
    September 22, 2023
    Date of Event
    September 8, 2023
    Report Date
    October 12, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 25-SEP-2023. H.6. INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE 2 PHOTOS, AND 25 SAMPLES, 7 SAMPLE RETURNED FROM BATCH 3174476 AND 18 SAMPLE RETURNED FROM BATCH 3142768, SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF DISCOLORATION / VARIATION IN COLOR / CLOUDY AND PACKAGE DAMAGED / DEFECTIVE / OTHER WERE CONFIRMED UPON INSPECTION OF THE SAMPLES AND PHOTOS. ANALYSIS OF THE SAMPLES AND PHOTOS SHOWED THAT THE BOTTOM WEB OF THE SAMPLES WAS CLOUDY AND IRREGULAR. BD DETERMINED THAT THE CAUSE OF THE FAILURE WAS LIKELY A RESULT OF POOR RAW MATERIALS FORM OUR SUPPLIER. A NOTIFICATION AND REQUEST FOR AN INVESTIGATION INTO THE OBSERVED FAILURE HAS BEEN SENT TO OUR SUPPLIER. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4: MEDICAL DEVICE LOT #: 3142768. D4: MEDICAL DEVICE EXPIRATION DATE: 31MAY2028. H4: DEVICE MANUFACTURE DATE: 01JUN2023. D4: MEDICAL DEVICE LOT #: 3174476. D4: MEDICAL DEVICE EXPIRATION DATE: 30JUN2028. H4: DEVICE MANUFACTURE DATE: 30JUN2023. H3: 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 · 0

    IT WAS REPORTED THAT THE BD¿10ML SYRINGE HAD MOISTURE PRESENT. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: PLEASE FIND BELOW THE PRODUCT DESCRIPTION AND THE LOT NUMBERS AFFECTED RE: CONDENSATION?/PATCHY CLOUDY APPEARANCE INSIDE THE 10 ML SYRINGES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿10ML SYRINGE HAD MOISTURE PRESENT. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: PLEASE FIND BELOW THE PRODUCT DESCRIPTION AND THE LOT NUMBERS AFFECTED RE: CONDENSATION/PATCHY CLOUDY APPEARANCE INSIDE THE 10 ML SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1267732 BD¿10ML SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) 3174476

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown