BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULIN SYRINGE

    MDR report key: 11547860 · Received March 22, 2021

    Report

    Report Number
    1920898-2021-00330
    Event Type
    Malfunction
    Date Received
    March 22, 2021
    Date of Event
    January 20, 2021
    Report Date
    March 22, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311786
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: NA. DATE RECEIVED BY MANUFACTURER: BD WAS INITIALLY MADE AWARE OF THIS COMPLAINT ON (B)(6) 2021 . AT THAT TIME, BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER, IT WAS EVALUATED AS A NON-REPORTABLE INCIDENT. ADDITIONAL INFORMATION WAS LATER RECEIVED ON 2021-03-19 VIA THE BD INVESTIGATION THAT CHANGED THE REPORTABILITY DETERMINATION. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THIS COMPLAINT IS NOW CONSIDERED TO BE AN MDR REPORTABLE INCIDENT. INVESTIGATION SUMMARY: INVESTIGATION SUMMARY: CUSTOMER RETURNED (5) LOOSE 3/10CC, 8MM SYRINGES. CUSTOMER STATES THAT THERE IS NO NEEDLE ATTACHED. ALL RETURNED SYRINGES WERE EXAMINED AND 4 OUT OF 5 WERE RETURNED WITH THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. NO DEFECTS WERE OBSERVED ON THE REMAINING SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 00835181. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200886538] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (HUB SEPARATES) COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. (B)(6) 2021 , HOLDREGE RECEIVED A PHOTO COMPLAINT FROM MATERIAL #328512 AND LOT #0083518; SYRINGE 0.3ML 31G 6MM. INITIAL EVALUATION: EXAMINATION OF THE PHOTO INDICATES THAT THE NEEDLE ASSEMBLY UNIT WAS NOT ATTACHED TO THE PRINTED BARREL. THERE DID NOT APPEAR TO BE ANY DAMAGE TO THE TIP OF THE BARREL, CORE PIN DAMAGE, OR DAMAGE TO THE SYRINGE. THE SHIELD WAS ATTACHED TO THE HUB/CANNULA UNIT THEREFORE NO EXAMINATION COULD BE COMPLETED FOR DAMAGE OR EXCESSIVE ADHESIVE TO CAUSE THE SHIELD TO BE DIFFICULT TO REMOVE. MANUFACTURING EVALUATION: A REVIEW OF THE SYRINGE ASSEMBLY LINE WHERE THE SYRINGE IN QUESTION WAS PRODUCED WAS COMPLETED. PROCESS SUMMARY: THE AUTOMATIC SYRINGE ASSEMBLY MACHINE, WHICH FEEDS 0.3ML SYRINGE COMPONENTS (BARREL, STOPPER, PLUNGER, NEEDLE ASSEMBLY & CAP) AND ASSEMBLES THESE COMPONENTS INTO A SYRINGE. THIS MACHINE CONSISTS OF A BARREL CLEANING DIAL, LUBRICATION DIAL, PLUNGER/STOPPER ASSEMBLY DIAL, SYRINGE ASSEMBLY DIAL, AND VARIOUS INSPECTIONS AND TRANSFER DIALS. DEVICE HISTORY RECORD; L2L AND LOGBOOK EVALUATION: THE DEVICE HISTORY (DHR) FOR BATCH 0083518 WAS REVIEWED AND ZERO QUALITY NOTIFICATIONS WERE WRITTEN FOR ISSUES RELATING TO THE ASSEMBLED SYRINGE DEFECT. THE SYRINGES WERE ASSEMBLED FROM 24MAY2020 TO 02JUN2020. DURING THE MANUFACTURING PROCESS, THE FOLLOWING INSPECTIONS ARE COMPLETED ON REGULAR INTERVALS: VISUAL INSPECTION EVERY HOUR: NEEDLE ASSEMBLY NOT FULLY SEATED OR IMPROPERLY SEATED ON BARREL TIP: HUB TO BARREL GAP MEASUREMENT (PIN GAUGE USED WHEN DEVIATION IS SUSPECTED). VISUAL INSPECTION EVERY HOUR: MISSING COMPONENT. VISUAL INSPECTION EVERY HOUR: DAMAGED / DEFECTIVE COMPONENTS. FUNCTIONAL INSPECTION EVERY 2 HOURS: HUB REMOVAL FORCE. IF A DEFECT IS FOUND DURING AN INSPECTION A QUALITY NOTIFICATION IS INITIATED. MAINTENANCE DISPATCH (L2L) WAS REVIEWED, AND NO DISPATCHES WERE CREATED FROM 24MAY2020 TO 02JUN2020 THAT WOULD CAUSE THE NEEDLE ASSEMBLY UNIT TO BECOME UNATTACHED. ROOT CAUSE: ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. DHR, L2L DISPATCHES, LOGBOOK ENTRIES WERE LOOKED AT, NOTHING WAS FOUND PERTAINING TO THIS DEFECT. CAPA# (B)(4) HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 6 RELION® INSULIN SYRINGES HAD ISSUES WITH THE NEEDLE HUB SEPARATING AND REMAINING IN THE SHIELD DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RELION CONSUMER REPORTED, REMOVING SHIELD AND FINDING NO NEEDLE ATTACHED. 6 SYRINGES AFFECTED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437228 RELION INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328512 0083518 00681131311786

    Patients

    Seq Age Sex Outcome Treatment
    1