BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14249994 · Received April 29, 2022

    Report

    Report Number
    1920898-2022-00304
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Date of Event
    April 7, 2022
    Report Date
    April 29, 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
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL: YES. D9: RETURNED TO MANUFACTURER ON: 19-MAY-2022. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (2) 0.5ML, 31 GAUGE, 8MM SYRINGES FROM LOT 9231071. THE FIRST 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. THE REMAINING SYRINGE WAS RETURNED FULLY INTACT. A NEEDLE SHIELD PULL FORCE TEST WAS PERFORMED ON THE SYRINGE. THE NEEDLE SHIELD REQUIRED 2.53 LBS OF FORCE TO BE REMOVED. THE HUB REMAINED ATTACHED TO THE BARREL OF THE SYRINGE. THE SPECIFICATION STATES THAT ALL PULL FORCES WITHIN THE RANGE OF 0.85 LBS TO 5.95 LBS ARE ACCEPTABLE. WITH THE NEEDLE HUB ATTACHED AND THE NEEDLE SHIELD BEING WITHIN PULL FORCE SPECIFICATION, THE REPORT OF THE HUB SEPARATING FROM THE BARRELS COULD NOT BE CONFIRMED FOR THIS SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9231071. 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 SAMPLES RECEIVED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF NEEDLE HUB SEPARATION IN 1 OF THE 2 SAMPLES. CAPA (B)(4) HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED TWICE THAT WHILE USING A RELION INSULIN SYRINGES 1/2ML 31 GAUGE, 8MM (5/16") U-100 100 COUNT, THE HUB SEPARATED FROM THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STATED, NEEDLE HUB SEPARATED WHEN REMOVING NEEDLE SHIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED TWICE THAT WHILE USING A RELION INSULIN SYRINGES 1/2ML 31 GAUGE, 8MM (5/16") U-100 100COUNT, THE HUB SEPARATED FROM THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STATED, NEEDLE HUB SEPARATED WHEN REMOVING NEEDLE SHIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104899 RELION INSULIN SYRINGES 1/2ML 31 GAUGE, 8MM (5/16") U-100 100COUNT PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328509 9231071 00681131311762

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown