BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULIN SYRINGE 3/10ML 29G X 8MM

    MDR report key: 13401200 · Received January 31, 2022

    Report

    Report Number
    1920898-2022-00049
    Event Type
    Malfunction
    Date Received
    January 31, 2022
    Date of Event
    January 12, 2022
    Report Date
    April 11, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311786
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 07-FEB-2022. H.6. INVESTIGATION: CUSTOMER RETURNED A SINGLE 0.3ML, 31 GAUGE, 8MM SYRINGE FROM LOT 1102423. THE SYRINGE HAD ITS NEEDLE SHIELD AND HUB SEPARATE FROM THE BARREL. THE HUB HAS BECOME LODGED INSIDE THE SHIELD. THERE IS NO DAMAGE TO EITHER THE CONNECTOR AT THE DISTAL TIP OF THE BARREL OR ITS RESPECTIVE NEEDLE HUB. NO SIGNS OF USE AND NO OTHER DEFECTS FOUND. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 1102423 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATION NOTED FOR CRACKED HUBS. BASED ON THE SAMPLE RECEIVED, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF NEEDLE HUB SEPARATION. CAPA#1630423 WAS INITIATED. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING RELION INSULIN SYRINGE 3/10ML 29G X 8MM ONE NEEDLE HUB SEPARATED FROM THE DEVICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328512 BATCH NO. 1102423. RELION CONSUMER REPORTED, WHEN SHE REMOVED THE NEEDLE SHIELD, NEEDLE HUB SEPARATED. 1 SYRINGE AFFECTED. LOT: 1102423. CATALOG: 328512.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING RELION INSULIN SYRINGE 3/10ML 29G X 8MM ONE NEEDLE HUB SEPARATED FROM THE DEVICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328512. BATCH NO. 1102423. RELION CONSUMER REPORTED, WHEN SHE REMOVED THE NEEDLE SHIELD, NEEDLE HUB SEPARATED. 1 SYRINGE AFFECTED. LOT: 1102423. CATALOG: 328512.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902691 RELION INSULIN SYRINGE 3/10ML 29G X 8MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328512 1102423 00681131311786

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown