BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 8MM TW 10BAG 500 TWN

    MDR report key: 9807021 · Received March 9, 2020

    Report

    Report Number
    1920898-2020-00218
    Event Type
    Malfunction
    Date Received
    March 9, 2020
    Date of Event
    February 18, 2020
    Report Date
    March 18, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY CUSTOMER RETURNED (40) 3/10CC, 8MM, 31G SYRINGES (20 IN OPEN POLY BAGS, 20 IN SEALED POLY BAGS) FROM LOT # 9042911. CUSTOMER STATES THAT THERE IS BLACK DISCOLORATION ON THE NEEDLE. ALL RETURNED SYRINGES WERE EXAMINED AND 2 SYRINGES (BOTH FROM THE OPEN POLY BAGS) EXHIBITED MATERIAL ON THE CANNULA SHAFT. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY EPOXY/ADHESIVE SPLATTER ON THE CANNULA. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 9042911 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. INVESTIGATION CONCLUSION: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION : NO ROOT CAUSE DETERMINED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 0.3ML 31GA 8MM TW 10BAG 500 TWN HAD FOREIGN MATTER ON THE NEEDLE. THIS OCCURRED ON 2 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLACK DISCOLORATION ON NEEDLE. THE HCP SAID 5~6EA OF SYRINGES IN THE BOX WERE DEFECTIVE, BUT ALREADY THREW AWAY, ONLY 1EA WAS LEFT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 0.3ML 31GA 8MM TW 10BAG 500 TWN HAD FOREIGN MATTER ON THE NEEDLE. THIS OCCURRED ON 2 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLACK DISCOLORATION ON NEEDLE. THE HCP SAID 5~6EA OF SYRINGES IN THE BOX WERE DEFECTIVE, BUT ALREADY THREW AWAY, ONLY 1EA WAS LEFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267830 SYRINGE 0.3ML 31GA 8MM TW 10BAG 500 TWN SYRINGE FMF BD MEDICAL - DIABETES CARE 9042911

    Patients

    Seq Age Sex Outcome Treatment
    1 Other