BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELION INSULIN SYRINGE

    MDR report key: 8805167 · Received July 18, 2019

    Report

    Report Number
    1920898-2019-00685
    Event Type
    Injury
    Date Received
    July 18, 2019
    Date of Event
    June 26, 2019
    Report Date
    August 9, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311748
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER RETURNED (20) 1CC, 8MM, 31G RELION SYRINGES (10 LOOSE, 10 IN A SEALED POLY BAG) FROM LOT # 8190574. CUSTOMER STATES THAT AFTER INJECTION IN BOTH HER LEFT AND RIGHT THIGH, SHE NOTICED "RED STREAKS" THAT LATER BECAME "WARM" TO THE TOUCH AND "ITCHY". ALL RETURNED SYRINGES WERE TESTED FOR POINT GEOMETRY, LUBE, AND CANNULA OD (SPECS: OUTER DIAMETER FOR 31G: 0.0100¿-0.0105¿). ALL OBSERVATIONS FALL WITHIN SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8190574. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ITCHY SKIN AND RED MARKS OCCURRED AFTER USE WITH A RELION® INSULIN SYRINGE . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, RELION CONSUMER STATED: AFTER INJECTION IN BOTH HER LEFT AND RIGHT THIGH, SHE NOTICED "RED STREAKS" THAT LATER BECAME "WARM" TO THE TOUCH AND "ITCHY". IT HAPPENED ON (B)(6) 2019 AND (B)(6) 2019. 8 SYRINGES WERE USED BETWEEN THESE TWO DATES BEFORE DOCTORS VISIT. STATED: SHE TAKES 5 INJECTIONS PER DAY. STATED: WENT TO SEE HER PRIMARY DOCTOR ON (B)(6) 2019 WHO SUGGESTED SHE USE A DIFFERENT BRAND. STATED: NO MEDICATION OR FOLLOW UP VISITS NECESSARY. STATED: SHE WIPES THE NEEDLE WITH A ALCOHOL SWAB BEFORE USE. STATED ONCE THE ITCHING STOPS AND REDNESS GOES AWAY, A BRUISE IS LEFT BEHIND. LOT: 8190574, ITEM: 1ML, 8MM, 31G OCCURRENCE DATE: (B)(6) 2019" COMPLAINT 2 OF 2: DATE OF OCCURRENCE (B)(6) 2019.

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: N/A. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8190574. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ITCHY SKIN AND RED MARKS OCCURRED AFTER USE WITH A RELION® INSULIN SYRINGE . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, RELION CONSUMER STATED: AFTER INJECTION IN BOTH HER LEFT AND RIGHT THIGH, SHE NOTICED "RED STREAKS" THAT LATER BECAME "WARM" TO THE TOUCH AND "ITCHY". IT HAPPENED ON (B)(6) 2019 AND (B)(6) 2019. 8 SYRINGES WERE USED BETWEEN THESE TWO DATES BEFORE DOCTORS VISIT. STATED: SHE TAKES 5 INJECTIONS PER DAY. STATED: WENT TO SEE HER PRIMARY DOCTOR ON (B)(6) 2019 WHO SUGGESTED SHE USE A DIFFERENT BRAND. STATED: NO MEDICATION OR FOLLOW UP VISITS NECESSARY. STATED: SHE WIPES THE NEEDLE WITH A ALCOHOL SWAB BEFORE USE. STATED ONCE THE ITCHING STOPS AND REDNESS GOES AWAY, A BRUISE IS LEFT BEHIND. LOT: 8190574, ITEM: 1ML, 8MM, 31G OCCURRENCE DATE: (B)(6) 2019". COMPLAINT 2 OF 2: DATE OF OCCURRENCE (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599381 RELION INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8190574 00681131311748

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention