BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELION INSULIN SYRINGE

    MDR report key: 8465777 · Received March 29, 2019

    Report

    Report Number
    1920898-2019-00294
    Event Type
    Injury
    Date Received
    March 29, 2019
    Date of Event
    March 8, 2019
    Report Date
    April 2, 2019
    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
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (3) USED 0.3ML 31G 8MM INSULIN SYRINGES FROM LOT #8211747 AND (4) USED 0.3ML 31G 8MM INSULIN SYRINGES FROM LOT # 8155852. CONSUMER REPORTED NEEDLE WILL NOT PENETRATE DOGS INJECTION SITE. ALL (7) RETURNED SYRINGES WERE EXAMINED AND TESTED FOR POINT GEOMETRY, OUTER DIAMETER AND LUBE COVERAGE. THE FOLLOWING WAS OBSERVED (SPECS: OUTER DIAMETER FOR 31G: 0.0100¿- 0.0105¿): - DATA: POINT (PE/NPE) OUTER DIAMETER (IN) LUBE - SAMPLE 1 GOOD/GOOD 0.0102 GOOD - SAMPLE 2 GOOD/GOOD 0.0102 GOOD - SAMPLE 3 GOOD/GOOD 0.0102 GOOD - SAMPLE 4 GOOD/GOOD 0.0102 GOOD - SAMPLE 5 GOOD/GOOD 0.0102 GOOD - SAMPLE 6 GOOD/GOOD 0.0102 GOOD - SAMPLE 7 GOOD/GOOD 0.0101 GOOD A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #8211747. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED FOR ADHESIVE ON CANNULA A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #8155852. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. 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 RELION® INSULIN SYRINGE WOULD NOT PENETRATE THE INJECTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PET OWNER REPORTED NEEDLE WILL NOT PENETRATE DOGS INJECTION SITE. STATED SHE TRIED 4 DIFFERENT INJECTION SPOTS BUT DID NOT WORK, NEEDLE WOULD NOT PUNCTURE SITE. WAS SUCCESSFUL WITH A SECOND SYRINGE. SAMPLE AVAILABLE TO SEND IN. LOT: 8211747, EXPIRATION DATE NOT AVAILABLE. OCCURRENCE DATE: (B)(6) 2019. ITEM: 8MM, 31G, 3/10ML. STATED TAKING HER DOG TO VETERINARIAN THURDAY (B)(6) 2019 TO DISCUSS ISSUE AND ANOTHER OPTION FOR HER PET. WILL BE REACHING OUT TO CONSUMER ON (B)(6)2019 IN AFTERNOON FOR FOLLOW UP.

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8211747, MEDICAL DEVICE EXPIRATION DATE: N/A, DEVICE MANUFACTURE DATE: 2018-09-20; MEDICAL DEVICE LOT #: 8155852, MEDICAL DEVICE EXPIRATION DATE: N/A, DEVICE MANUFACTURE DATE: 2018-07-30." A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED RELION® INSULIN SYRINGE WOULD NOT PENETRATE THE INJECTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PET OWNER REPORTED NEEDLE WILL NOT PENETRATE DOGS INJECTION SITE. STATED SHE TRIED 4 DIFFERENT INJECTION SPOTS BUT DID NOT WORK, NEEDLE WOULD NOT PUNCTURE SITE. WAS SUCCESSFUL WITH A SECOND SYRINGE. SAMPLE AVAILABLE TO SEND IN. LOT: 8211747, EXPIRATION DATE NOT AVAILABLE. OCCURRENCE DATE: (B)(6) 2019. ITEM: 8MM, 31G, 3/10ML. STATED TAKING HER DOG TO VETERINARIAN THURSDAY (B)(6) 2019 TO DISCUSS ISSUE AND ANOTHER OPTION FOR HER PET. WILL BE REACHING OUT TO CONSUMER ON (B)(4) 2019 IN AFTERNOON FOR FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257732 RELION INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE SEE H.10 00681131311786

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention