BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ II INSULIN SYRINGE

    MDR report key: 15341568 · Received September 1, 2022

    Report

    Report Number
    1920898-2022-00598
    Event Type
    Malfunction
    Date Received
    September 1, 2022
    Date of Event
    August 9, 2022
    Report Date
    September 8, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED SEVERAL PHOTOS OF A 0.3ML 30GA 8MM SYRINGE FROM LOT # 9042904. CUSTOMER STATES THE NEEDLE CAME LOOSE AND DISPLACED. THE ATTACHED PHOTOS WERE EXAMINED AND EXHIBITED THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL, THE CANNULA WAS NO LONGER ATTACHED TO THE BARREL. MANUFACTURING (HOLDREGE) WILL BE NOTIFIED OF THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9042904. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS [200807033, 200807032, 200806766] 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 OF NEEDLE SEPARATE. 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. DATE COMPLAINT RECEIVED IN HOLDREGE: 04TH OCT 2022. CATALOG AND BATCH #: 328322 AND 9042904. CATALOG DESCRIPTION: SYRINGE 0.3ML 30GA 8MM 10BAG 500 L AMR ISSUE: HUB SEPARATES. ANALYSIS OF SAMPLE: BASED ON RETURNED SAMPLE ANALYSIS FROM COMPLAINT HANDLING DEPARTMENT, THE SAMPLE WAS EXAMINED, AND THE SYRINGE WAS RETURNED WITH THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. PROCESS: THE AUTOMATIC SYRINGE ASSEMBLY MACHINE FEEDS SYRINGE COMPONENTS (BARREL, STOPPER, PLUNGER, NEEDLE ASSEMBLY & CAP) AND ASSEMBLES THESE COMPONENTS. THIS MACHINE CONSISTS OF A BARREL CLEANING DIAL, LUBRICATION DIAL, PLUNGER/STOPPER ASSEMBLY DIAL, SYRINGE ASSEMBLY DIAL, AND VARIOUS INSPECTIONS AND TRANSFER DIALS. INVESTIGATION: THERE WERE THREE (3) NOTIFICATIONS [200807033, 200807032, 200806766] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. REVIEWED L2L (LEADING TO LEAN) MAINTENANCE DISPATCH HISTORY AND DID NOT FIND ANY DISPATCHES PERTAINING TO DEFECT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. CORRECTIVE ACTION- CAPA 1630423 HAS BEEN OPENED TO ADDRESS THIS ISSUE. QUALITY: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE?¿ II INSULIN SYRINGE NEEDLE CAME LOOSE AND BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "IN THE PACK OF 30 SYRINGES FOR INSULIN ULTRA-FINE II WITH 0.3MM, 8MM NEEDLE, THE NEEDLE CAME LOOSE AND DISPLACED. I EMPHASIZE THAT AT THE TIME IT WAS STILL VALID. BUT I GOT SICK AND DIDN'T SEND A MESSAGE. EXPENSIVE PRODUCT TO LOSE A SYRINGE UNIT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ II INSULIN SYRINGE NEEDLE CAME LOOSE AND BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE: "IN THE PACK OF 30 SYRINGES FOR INSULIN ULTRA-FINE II WITH 0.3MM, 8MM NEEDLE, THE NEEDLE CAME LOOSE AND DISPLACED. I EMPHASIZE THAT AT THE TIME IT WAS STILL VALID. BUT I GOT SICK AND DIDN'T SEND A MESSAGE. EXPENSIVE PRODUCT TO LOSE A SYRINGE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1347253 BD ULTRA-FINE¿ II INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9042904

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown