BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALLERGY SYRINGE TRAY 1ML 27G X 1/2 IN BD PRECISIONGLIDE

    MDR report key: 8550390 · Received April 25, 2019

    Report

    Report Number
    1920898-2019-00384
    Event Type
    Malfunction
    Date Received
    April 25, 2019
    Date of Event
    March 19, 2019
    Report Date
    April 5, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    30382903055402
    PMA / PMN Number
    K980580
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8172737. MEDICAL DEVICE EXPIRATION DATE: 2023-06-30. DEVICE MANUFACTURE DATE: 2018-06-21. MEDICAL DEVICE LOT #: 8227671. MEDICAL DEVICE EXPIRATION DATE: 2023-09-30. DEVICE MANUFACTURE DATE: 2018-08-15. INVESTIGATION SUMMARY: CUSTOMER RETURNED A PHOTO OF 1 CC SYRINGES. CUSTOMER STATES THAT THERE WAS PLASTIC ON THE NEEDLES. THE PHOTO WAS EXAMINED AND EXHIBITED MATERIAL ON THE CANNULA OF BOTH SHOWN SYRINGES. HOWEVER, IT IS DIFFICULT TO DETERMINE THE IDENTITY OF THE MATERIALS SOLELY FROM THE PHOTO. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 8172737. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 8227671. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. INVESTIGATION CONCLUSION: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE, HOWEVER, IT IS DIFFICULT TO DETERMINE THE IDENTITY OF THE MATERIALS SOLELY FROM THE PHOTO. 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: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE MATERIAL ON THE SAMPLE CANNOT BE DETERMINED FROM THE PHOTO. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    MATERIAL NO.: 305540. BATCH NO.: 8172737, 8227671. IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FOREIGN MATTER WITH THE BD ALLERGY SYRINGE TRAY 1 ML 27 G X 1/2 IN BD PRECISIONGLIDE¿ THERE WAS PLASTIC ON THE NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLASTIC ON THE NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343860 BD ALLERGY SYRINGE TRAY 1ML 27G X 1/2 IN BD PRECISIONGLIDE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE SEE H.10 30382903055402

    Patients

    Seq Age Sex Outcome Treatment
    1 Other