BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ NEEDLE

    MDR report key: 17442216 · Received August 2, 2023

    Report

    Report Number
    1920898-2023-00502
    Event Type
    Malfunction
    Date Received
    August 2, 2023
    Date of Event
    June 5, 2023
    Report Date
    August 15, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    PMA / PMN Number
    K161170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3. 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

    H6: INVESTIGATION SUMMARY: NO PICTURES OR SAMPLES WERE AVAILABLE FOR INVESTIGATION REGARDING NEEDLE ECLIPSE 18X1-1/2 RB FROM LOT #3096615 REGARDING ITEM #305712 WITH THE REPORTED COMPLAINT OF ¿CORING NEEDLE¿. WITHOUT ANY PICTURES OR RETURNED SAMPLES, A ROOT CAUSE CANNOT BE DETERMINED. CANNULA CONDITION IS INSPECTED EACH HOUR DURING PRODUCTION, LOOKING SPECIFICALLY FOR HOOKED/DAMAGED POINT, DOUBLE, INVERTED, AND BENT/BLUNT CANNULA (WHICH MAY CONTRIBUTE TO THE EXPERIENCED CORING). INSPECTION RECORDS DID NOT INDICATE ANY NONCONFORMANCES. ALL ASSEMBLED NEEDLES ALSO PASS UNDER THE POINT INSPECT MACHINE. ALL PARTS ARE CONSIDERED "BAD" UNTIL THEY MEET CERTAIN REQUIREMENTS TO PASS AS "GOOD". THE POINT/GRIND IS HOW THE INSPECTION CAMERA LOOKS AT THE BEVEL AND IF THE POINT WAS DAMAGED IT WOULD CALL THE PART BAD AND WOULD REJECT IT. CANNULA (PART NUMBER 700031627) BATCHES 1285541, 2192807, AND 2215248 WERE USED DURING THE PRODUCTION OF FINISHED PRODUCT BATCH 3096615. CANNULA IS RECEIVED FROM BD - COLUMBUS, WHO WERE CONTACTED WITH REGARDS TO THE COMPLAINT. NO MANUFACTURING DEFECTS WERE NOTED DURING THE PRODUCTION OF THE PREVIOUSLY MENTIONED BATCHES. THE VENDOR STATED THEY DO NOT PERFORM ANY TESTS FOR CORING ON ECLIPSE PRODUCT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #3096615. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. WITHOUT HAVING SAMPLES TO INSPECT, IT IS DIFFICULT TO DETERMINE A LIKELY ROOT CAUSE. SINCE ALL IN-PROCESS INSPECTIONS MET ACCEPTABILITY REQUIREMENTS, IT IS UNLIKELY THE COMPLAINT CONDITION WAS GENERATED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE EXPERIENCED CORING. THIS IS 2 OF 3 RELATED EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING PREPARATION OF INTRAVENOUS MEDICATIONS, THERE HAS BEEN INCREASED CORING OF VIALS WHEN USING A CERTAIN NEEDLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE EXPERIENCED CORING. THIS IS 2 OF 3 RELATED EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING PREPARATION OF INTRAVENOUS MEDICATIONS, THERE HAS BEEN INCREASED CORING OF VIALS WHEN USING A CERTAIN NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261057 BD ECLIPSE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL - DIABETES CARE 3096615

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown