BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ II INSULIN SYRINGE

    MDR report key: 16653060 · Received March 30, 2023

    Report

    Report Number
    1920898-2023-00180
    Event Type
    Malfunction
    Date Received
    March 30, 2023
    Date of Event
    March 14, 2023
    Report Date
    July 21, 2023
    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

    H6: INVESTIGATION SUMMARY A COMPLAINT LOT HISTORY CHECK WAS PERFORMED ON LOT # 2031535 FOR PLUNGER DIFFICULT/UNABLE TO MOVE. THIS IS THE 1ST RELATED COMPLAINT FOR PLUNGER DIFFICULT/UNABLE TO MOVE ON LOT # 2031535. INVESTIGATION SUMMARY: THE CUSTOMER RETURNED (1) 0.3ML 30GA 8MM SYRINGE, REPORTING PLUNGER ROD DAMAGE AND THE PLUNGER DIFFICULT/UNABLE TO OPERATE. THE SYRINGE WAS VISUALLY EXAMINED AND OBSERVED DAMAGED/DEFORMED PLUNGER ROD. UPON VISUAL EXAMINATION, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER-INDICATED FAILURE OF THE PLUNGER DIFFICULT/UNABLE TO MOVE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2031535. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. CONFIRMED: BASED ON THE SAMPLE RECEIVED, EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER-INDICATED FAILURE. 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 THE IDENTIFICATION OF EMERGING TRENDS. CATALOG #: 326638 BATCH #: 2031535 CATALOG DESCRIPTION: SYRINGE 0.3ML 30GA 8MM 7BAG 420CAS JP ISSUE: DIFFICULT TO OPERATE ANALYSIS OF SAMPLE: THE CUSTOMER RETURNED (1) 0.3ML 30GA 8MM SYRINGE, REPORTING PLUNGER ROD DAMAGE AND THE PLUNGER DIFFICULT/UNABLE TO OPERATE. THE SYRINGE WAS VISUALLY EXAMINED BY COMPLAINT¿S INVESTIGATION DEPARTMENT AND OBSERVED DAMAGED/DEFORMED PLUNGER ROD. UPON VISUAL EXAMINATION, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER-INDICATED FAILURE OF THE PLUNGER DIFFICULT/UNABLE TO MOVE. PROCESS: THE AUTOMATIC SYRINGE ASSEMBLY MACHINE FEEDS 0.3ML 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: A REVIEW OF THE DEVICE HISTORY RECORD AND LEADING 2LEAN (L2L) WAS COMPLETED. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. ROOT CAUSE ¿ THERE WERE NO QUALITY NOTIFICATIONS OR DISPATCHES THAT PERTAINED TO THE COMPLAINT; THEREFORE, NO ROOT CAUSE CAN BE DETERMINED. QUALITY: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITIONS WOULD CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA TO IDENTIFY EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    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 BD ULTRA-FINE¿ II INSULIN SYRINGE STOPPER WAS BENT AND THE PLUNGER WAS DIFFICULT TO MOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "ACCORDING TO THE USER'S REPORT, BEFORE USING, PLUNGER ROD END WAS FOUND TO BENT AND COULD NOT BE PUSHED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ II INSULIN SYRINGE STOPPER WAS BENT AND THE PLUNGER WAS DIFFICULT TO MOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "ACCORDING TO THE USER'S REPORT, BEFORE USING, PLUNGER ROD END WAS FOUND TO BENT AND COULD NOT BE PUSHED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580968 BD ULTRA-FINE¿ II INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 2087442

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown