BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31G 8MM WHOLEUNIT 10BG 500

    MDR report key: 9539888 · Received January 2, 2020

    Report

    Report Number
    1920898-2019-01505
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    December 16, 2019
    Report Date
    January 16, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908438032
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY : SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED, AND THIS IS THE 1ST RELATED COMPLAINT FOR FOREIGN MATTER IN SYRINGE ON LOT # 9112701. INVESTIGATION SUMMARY: CUSTOMER RETURNED (3) 3/10CC, 8MM, 31G SYRINGES IN AN OPEN POLY BAG FROM LOT # 9112701. CUSTOMER STATES THAT THERE WAS FLUID IN THE SYRINGE BEFORE USE. ALL RETURNED SYRINGES WERE EXAMINED AND NO FLUID OR ANY OTHER FOREIGN MATTER WAS OBSERVED IN OR ON THE SAMPLES. ALSO, ALL SAMPLES WERE TESTED, AND NO MATERIAL CAME OUT OF THE CANNULA WHEN FULLY DEPRESSING THE PLUNGER ROD. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9112701. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WERE THREE (3) NOTIFICATIONS [200820743, 200820454, 200820624] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 0.3ML 31G 8MM WHOLEUNIT 10BG 500 EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328438, BATCH NO: 9112701. VERBATIM: ISSUE(S): FLUID IN SYRINGE BEFORE USE. HAS 2 SYRINGES TO RETURN. LOT #: 9112701A, ITEM #: 328438 AND DATE OF EVENT: UNKNOWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 0.3ML 31G 8MM WHOLEUNIT 10BG 500 EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328438. BATCH NO: 9112701. VERBATIM: ISSUE(S): FLUID IN SYRINGE BEFORE USE. HAS 2 SYRINGES TO RETURN. LOT #: 9112701A. ITEM #: 328438. DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4915 SYRINGE 0.3ML 31G 8MM WHOLEUNIT 10BG 500 PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328438 9112701 00382908438032

    Patients

    Seq Age Sex Outcome Treatment
    1 Other