BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGES 0.3ML 31GA 8MM

    MDR report key: 9872112 · Received March 24, 2020

    Report

    Report Number
    1920898-2020-00297
    Event Type
    Malfunction
    Date Received
    March 24, 2020
    Date of Event
    February 13, 2020
    Report Date
    March 30, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311786
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY CUSTOMER RETURNED (1) 3/10CC, 8MM, 31G RELION SYRINGE IN AN OPEN POLY BAG WITH PART OF THE SHELF CARTON FROM LOT # 9210510. CUSTOMER STATES THAT THE NEEDLE HUB SEPARATED INTO NEEDLE SHIELD. THE RETURNED SYRINGE WAS TESTED AND THE HUB-NEEDLE ASSEMBLY DID NOT SEPARATE FROM THE BARREL WHEN THE SHIELD WAS REMOVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 9210510 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200837337, 200837237] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATION [200837775] NOTED FOR OUT OF SPEC SHIELD PULL. INVESTIGATION CONCLUSION 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. 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 ISSUE IS UNCONFIRMED. 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 AN UNSPECIFIED NUMBER OF SYRINGES 0.3ML 31GA 8MM EXPERIENCED HUB SEPARATION FROM THE DEVICE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328512, BATCH NO. 9210510. CONSUMER REPORTED NEEDLE HUB SEPARATED AND STAYED IN THE SHIELD BEFORE INJECTION. CONSUMER DOES NOT RE-USE. DATE OF EVENT: 02-13-20.

    Additional Manufacturer Narrative · 1

    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 SYRINGES 0.3ML 31GA 8MM EXPERIENCED HUB SEPARATION FROM THE DEVICE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328512, BATCH NO. 9210510. VERBATIM: CONSUMER REPORTED NEEDLE HUB SEPARATED AND STAYED IN THE SHIELD BEFORE INJECTION. CONSUMER DOES NOT RE-USE. DATE OF EVENT: (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339622 SYRINGES 0.3ML 31GA 8MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328512 9210510 00681131311786

    Patients

    Seq Age Sex Outcome Treatment
    1 Other