BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELION INSULIN SYRINGE

    MDR report key: 10125519 · Received June 5, 2020

    Report

    Report Number
    1920898-2020-00624
    Event Type
    Injury
    Date Received
    June 5, 2020
    Date of Event
    May 20, 2020
    Report Date
    July 7, 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
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION HAS BEEN UPDATED/CORRECTED: H.6 INVESTIGATION SUMMARY: SAMPLE WILL BE FORWARDED TO MANUFACTURING (HOLDREGE) ON (B)(6)2020 FOR FURTHER REVIEW. INVESTIGATION CONCLUSION: BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (ADHESIVE CLOG) 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. H.6. METHOD CODES: 10. H.6. RESULT CODES: 114, 3233. H.6. CONCLUSION CODES: 11 H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF RELION® INSULIN SYRINGES EXPERIENCED DIFFICULT PLUNGER MOVEMENT, AN INABILITY TO/DIFFICULTY ASPRIATING. PRODUCT DEFECTS WERE NOTED DURING USE. THE PRODUCT DEFECTS RESULTED IN THE PATIENT/LAY USER EXPERIENCING A SERIOUS INJURY IN THE FORM OF HYPERGLYCEMIA. IT HAS NOT BEEN SPECIFIED WHETHER ANY MEDICAL INTERVENTION OR BOLUS DOSAGE WAS ADMINISTERED AS A RESULT OF THE HYPERGLYCEMIA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328512 BATCH NO. 9210511 VERBATIM: CONSUMER REPORTED THAT HIS GLUCOSE LEVEL WAS ELEVATED. HE THOUGHT THAT HE WAS GETTING THE INSULIN IN BUT REALIZED THAT THE NEEDLE WAS NOT DRAWING THE INSULIN. DATE OF EVENT: UNKNOWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: NA (B)(4). INVESTIGATION SUMMARY: LEVEL A INVESTIGATION - COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_2__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR GLUCOSE LEVEL AND DIFFICULT/UNABLE TO OPERATE (NOT DRAWING) ON LOT # 9210511. 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# 9210511. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. INVESTIGATION CONCLUSION: 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. 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 AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF RELION® INSULIN SYRINGES EXPERIENCED DIFFICULT PLUNGER MOVEMENT, AN INABILITY TO/DIFFICULTY ASPRIATING. PRODUCT DEFECTS WERE NOTED DURING USE. THE PRODUCT DEFECTS RESULTED IN THE PATIENT/LAY USER EXPERIENCING A SERIOUS INJURY IN THE FORM OF HYPERGLYCEMIA. IT HAS NOT BEEN SPECIFIED WHETHER ANY MEDICAL INTERVENTION OR BOLUS DOSAGE WAS ADMINISTERED AS A RESULT OF THE HYERGLYCEMIA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328512; BATCH NO. 9210511. CONSUMER REPORTED THAT HIS GLUCOSE LEVEL WAS ELEVATED. HE THOUGHT THAT HE WAS GETTING THE INSULIN IN BUT REALIZED THAT THE NEEDLE WAS NOT DRAWING THE INSULIN. DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588518 RELION INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 328512 9210511 00681131311786

    Patients

    Seq Age Sex Outcome Treatment
    1 Other