BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELION INSULIN SYRINGE

    MDR report key: 10022727 · Received May 4, 2020

    Report

    Report Number
    2243072-2020-00715
    Event Type
    Injury
    Date Received
    May 4, 2020
    Date of Event
    April 28, 2020
    Report Date
    May 20, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT ALLERGIC REACTION OCCURRED DURING USE WITH A RELION® INSULIN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2 COMPLAINTS) CONSUMER STATED THAT THAT SORES DEVELOP AROUND THE INJECTION SITE AFTER INJECTION. OVER THE YEARS IT SEEMED TO HAVE GOTTEN MUCH WORSE A FEW MONTHS AGO WHEN SHE HAD A SURGERY TO HAVE METAL PLATES AND SCREWS PUT IN HER NECK. D.3. MEDICAL DEVICE MANUFACTURER: BD MEDICAL ¿ DIABETES CARE ¿ HOLDREGE, NE / 68949. D.4 MEDICAL DEVICE CATALOG #: 328509. D.4. MEDICAL DEVICE LOT #: 9154593. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.2 MANUFACTURING LOCATION: BD MEDICAL ¿ DIABETES CARE ¿ HOLDREGE, NE / 68949. G.5. PMA / 510(K)#: K024112. H.6. METHOD CODES: 3331 & 4114. H.6. INVESTIGATION SUMMARY: A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9154593. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. 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. AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. 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 ALLERGIC REACTION OCCURRED DURING USE WITH A RELION® INSULIN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2 COMPLAINTS) CONSUMER STATED THAT THAT SORES DEVELOP AROUND THE INJECTION SITE AFTER INJECTION. OVER THE YEARS IT SEEMED TO HAVE GOTTEN MUCH WORSE A FEW MONTHS AGO WHEN SHE HAD A SURGERY TO HAVE METAL PLATES AND SCREWS PUT IN HER NECK.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: UNABLE TO PERFORM COMPLAINT LOT HISTORY CHECK FOR HARM/ALLERGIC REACTION, AND HARM/SKIN IRRITATION DUE TO UNKNOWN LOT NUMBER. 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. UNABLE TO PERFORM DHR CHECK FOR HARM/ALLERGIC REACTION, AND HARM/SKIN IRRITATION DUE TO UNKNOWN LOT NUMBER. AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALLERGIC REACTION OCCURRED DURING USE WITH AN UNSPECIFIED BD INSULIN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2 COMPLAINTS) CONSUMER STATED THAT SORES DEVELOP AROUND THE INJECTION SITE AFTER INJECTION. OVER THE YEARS IT SEEMED TO HAVE GOTTEN MUCH WORSE A FEW MONTHS AGO WHEN SHE HAD A SURGERY TO HAVE METAL PLATES AND SCREWS PUT IN HER NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486411 RELION INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9154593

    Patients

    Seq Age Sex Outcome Treatment
    1 Other