BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULIN SYRINGES 1/2ML 31 GAUGE, 8MM (5/16") U-100 100COUNT

    MDR report key: 15033637 · Received July 15, 2022

    Report

    Report Number
    1920898-2022-00457
    Event Type
    Malfunction
    Date Received
    July 15, 2022
    Date of Event
    June 16, 2022
    Report Date
    July 28, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311762
    PMA / PMN Number
    K190054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    CORRECTION: G.5. PMA / 510(K)#: K190054. THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 18-JUL-2022 H6: INVESTIGATION SUMMARY CUSTOMER RETURNED A 0.5ML, 31 GAUGE, 8MM SYRINGE FROM LOT 1242757. THE SYRINGE HAD ITS NEEDLE SHIELD AND HUB SEPARATE FROM THE BARREL. THE HUB HAS BECOME LODGED INSIDE THE SHIELD. THERE IS SOME MINOR DAMAGE AT THE LIP OF THE CONNECTOR. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1242757. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES RECEIVED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF NEEDLE HUB SEPARATION. CAPA PR1630423 HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RELION INSULIN SYRINGES 1/2ML 31 GAUGE, 8MM (5/16") U-100 100COUNT EXPERIENCED HUB SEPARATION FROM THE DEVICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ISSUE: RELION INSULIN SYRINGE - CUSTOMER STATES THAT THE SYRINGE IS UNSUABLE. WHEN SHE TOOK THE CAP OFF THE NEEDLE GOT STUCK IN THE CAP AND SHE CAN'T USE IT. THE WHOLE LITTLE PLASTIC PART GOT STUCK IN THE CAP. SHE BOUGHT A BOX AND THIS WAS ONE OF THE BAG.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RELION INSULIN SYRINGES 1/2ML 31 GAUGE, 8MM (5/16") U-100 100COUNT EXPERIENCED HUB SEPARATION FROM THE DEVICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ISSUE: RELION INSULIN SYRINGE - CUSTOMER STATES THAT THE SYRINGE IS UNSUABLE. WHEN SHE TOOK THE CAP OFF THE NEEDLE GOT STUCK IN THE CAP AND SHE CAN'T USE IT. THE WHOLE LITTLE PLASTIC PART GOT STUCK IN THE CAP. SHE BOUGHT A BOX AND THIS WAS ONE OF THE BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2890133 RELION INSULIN SYRINGES 1/2ML 31 GAUGE, 8MM (5/16") U-100 100COUNT PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328509 1242757 00681131311762

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown