BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE

    MDR report key: 13863687 · Received March 23, 2022

    Report

    Report Number
    1920898-2022-00180
    Event Type
    Malfunction
    Date Received
    March 23, 2022
    Date of Event
    March 7, 2022
    Report Date
    April 25, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION HAS BEEN UPDATED: D.10 DEVICE RETURNED TO MANUFACTURER: YES. D.10 DATE SAMPLES RECEIVED: 11-APR-2022. H.3 DEVICE RETURNED TO MANUFACTURER?: YES H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: UNKNOWN. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. D.4. MEDICAL DEVICE LOT #: 1123341. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2026. H.4. DEVICE MANUFACTURE DATE: 03-MAY-2021. D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 19-APR-2022. H.6. INVESTIGATION: CUSTOMER RETURNED TWO SYRINGES WITH NO POUCH FOR IDENTIFICATION. THESE SAMPLES WERE RETURNED IN A POLYBAG LABELED FOR 0.3ML, 29 GAUGE, 12.7MM SYRINGES FROM LOT 1123341. 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 3.00 LBS OF FORCE TO BE REMOVED. REMOVING THE NEEDLE SHIELDS FOUND THAT THE HUB WAS PROPERLY 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# 1123341. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. CAPA#1630423 WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE BARREL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE BARREL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727667 BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown