BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 1.0ML 29GA 1/2IN

    MDR report key: 10175257 · Received June 19, 2020

    Report

    Report Number
    1920898-2020-00703
    Event Type
    Malfunction
    Date Received
    June 19, 2020
    Date of Event
    June 1, 2020
    Report Date
    July 1, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (4) LOOSE 1CC, 12.7MM SYRINGES. CUSTOMER STATES THAT FM WAS FOUND ON NEEDLES AND SCRATCHES ALSO SEEM TO BE PRESENT. ALL RETURNED SYRINGES WERE EXAMINED AND NO SCRATCHES WERE OBSERVED ON THE CANNULA. HOWEVER, ONE SAMPLE EXHIBITED A PIECE OF ORANGE MATERIAL ON THE CANNULA AND ALL REMAINING SAMPLES EXHIBITED CLEAR MATERIAL ON THE CANNULA. A SMALL PORTION OF EACH OF THESE MATERIALS WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THE ORANGE MATERIAL IS MOST LIKELY POLYETHYLENE AND THE CLEAR MATERIAL IS MOST LIKELY SILICONE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9081523. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. - CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (FM ON CANNULA) - UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (SCRATCHES ON CANNULA) PROCESS SUMMARY: THIS OPERATION ASSEMBLES THE CANNULA INTO THE BARREL TIP AND APPLIES ADHESIVE TO HOLD THE CANNULA IN THE BARREL TIP. THE RACKS OF CANNULATED BARRELS THEN TRAVEL THROUGH AN OVEN WHICH USES IR LIGHT TO FACILITATE ADHESIVE RUN DOWN AND ULTRAVIOLET LIGHT TO CURE THE ADHESIVE THAT BONDS THE CANNULA TO THE BARREL TIP. THE CANNULATED BARRELS ARE THEN CONVEYED TO A MACHINE THAT INSPECTS FOR MISSING CANNULA, CANNULA HEIGHT, POINT QUALITY, ZERO LINE PLACEMENT, AND UV ADHESIVE. IT ALSO SUPPLIES LUBE TO THE CANNULA, FEATURES TWO LUMEN BLOWS, ASSEMBLES THE SHIELD TO THE BARREL/CANNULA ASSEMBLY, AND DETECTS FOR MISSING SHIELDS. THERE WERE NO QUALITY NOTIFICATIONS OR MAINTENANCE DISPATCHES DURING THE PRODUCTION OF THIS BATCH THAT PERTAINED TO THE COMPLAINT. ROOT CAUSE CANNOT BE DETERMINED. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE FOREIGN MATTER WAS FOUND ON 4 NEEDLES AND THE SYRINGES WERE UNABLE TO BE USED WITH A BD SYRINGE 1.0ML 29GA 1/2IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: WHEN REMOVING SHIELDS, FM WAS FOUND ON NEEDLES. THESE SYRINGES CANNOT THUS BE USED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE FOREIGN MATTER WAS FOUND ON 4 NEEDLES AND THE SYRINGES WERE UNABLE TO BE USED WITH A BD SYRINGE 1.0ML 29GA 1/2IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: WHEN REMOVING SHIELDS, FM WAS FOUND ON NEEDLES. THESE SYRINGES CANNOT THUS BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640394 BD SYRINGE 1.0ML 29GA 1/2IN PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9081523

    Patients

    Seq Age Sex Outcome Treatment
    1 Other