BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION® INSULIN SYRINGE

    MDR report key: 12973326 · Received December 9, 2021

    Report

    Report Number
    1920898-2021-01296
    Event Type
    Malfunction
    Date Received
    December 9, 2021
    Date of Event
    November 12, 2021
    Report Date
    January 24, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0160001. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2022-01-06. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED A 0.3ML, 31 GAUGE, 8MM SYRINGE LOT 0160001. THE SYRINGE DID NOT FEATURE ANY IMMEDIATELY OBSERVABLE DAMAGE. HOWEVER, WHEN TESTING THE SYRINGE¿S FUNCTIONALITY, NO FLUIDS COULD BE DRAWN INTO THE BODY OF THE SYRINGE. IT WAS ALSO NOTED THAT THE PLUNGER COULD NOT BE FULLY DEPRESSED. A WIRE WAS INSERTED INTO THE CANNULA OF THE SYRINGE AND AN OBSTRUCTION WAS ENCOUNTERED AT THE END CLOSE TO THE BARREL OF THE SYRINGE. THE OBSTRUCTION COULD NOT BE DISLODGED WITH THE WIRE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0160001. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE SAMPLE RECEIVED, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF A CLOG IN THE SYRINGE. ROOT CAUSE: MAINTENANCE DISPATCH # (B)(4) WAS CREATED FOR THE LUMEN BLOW NOT WORKING CORRECTLY. THE LUMEN BLOW IS LOCATED IN THE CASCADE SYSTEM. THE LUMEN BLOW MANIFOLD IS LOOSE AND NOT ALLOWING THE AIR TO BLOW THROUGH THE CANNULA PROPERLY.

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RELION® INSULIN SYRINGE NEEDLE WAS BLOCKED AND COULD NOT DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED PRESSED IN THE AIR INTO VIAL BUT THE NEEDLE WAS BLOCKED PLUNGER BOUNCES BACK"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RELION® INSULIN SYRINGE NEEDLE WAS BLOCKED AND COULD NOT DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED PRESSED IN THE AIR INTO VIAL BUT THE NEEDLE WAS BLOCKED PLUNGER BOUNCES BACK."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RELION® INSULIN SYRINGE NEEDLE WAS BLOCKED AND COULD NOT DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED PRESSED IN THE AIR INTO VIAL BUT THE NEEDLE WAS BLOCKED PLUNGER BOUNCES BACK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1870221 RELION® INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0160001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown