BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE ECLIPSE 25X5/8

    MDR report key: 20509627 · Received October 22, 2024

    Report

    Report Number
    2243072-2024-01066
    Event Type
    Malfunction
    Date Received
    October 22, 2024
    Date of Event
    September 22, 2024
    Report Date
    October 28, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903057597
    PMA / PMN Number
    K010188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    OUR QUALITY ENGINEER INSPECTED THE PHOTO SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF SAFETY MECHANISM FAILURE WAS NOT CONFIRMED UPON INSPECTION OF THE PHOTO. HOWEVER, BD CANNOT CONFIRM THE CAUSE OF THE FAILURE TO OUR MANUFACTURING PROCESS SINCE NO PHYSICAL SAMPLE WAS RETURNED. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X5/8 SAFETY MECHANISM FAILURE. IT WAS REPORTED BY THE CUSTOMER THAT THE SAFETY COVER DID NOT CLIP OVER NEEDLE AND COVER NEEDLE AFTER INJECTING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. (B)(4). PRODUCT PROBLEM REPORT: PRODUCT INFORMATION: PRODUCT CODE: 305781. PRODUCT DESCRIPTION: SYRINGE & NEEDLE 3CC 25G X 5/8IN & SAFETY ECLIPSE BX/50. LOT/SERIAL #: (B)(6). EXPIRY DATE: 2028-12-31. PROBLEM INFORMATION: CITE CUSTOMER COMPLAINT# (B)(4). INCIDENT DATE: 22-09-2024. THE SAFETY COVER DID NOT CLIP OVER NEEDLE AND COVER NEEDLE AFTER INJECTING.

    Description of Event or Problem · 0

    MATERIAL: 305759; BATCH#: 3360142. IT WAS REPORTED BY THE CUSTOMER THAT THE SAFETY COVER DID NOT CLIP OVER NEEDLE AND COVER NEEDLE AFTER INJECTING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. (B)(4). PRODUCT PROBLEM REPORT; PRODUCT INFORMATION; PRODUCT CODE: 305781; PRODUCT DESCRIPTION: SYRINGE & NEEDLE 3CC 25G X 5/8IN & SAFETY ECLIPSE BX/50 ; LOT/SERIAL #: (B)(6); EXPIRY DATE: 2028-12-31. PROBLEM INFORMATION **CITE CUSTOMER COMPLAINT#(B)(4)** INCIDENT DATE: 22-09-2024 THE SAFETY COVER DID NOT CLIP OVER NEEDLE AND COVER NEEDLE AFTER INJECTING. ADDITIONAL INFO: 1. KINDLY PROVIDE THE BATCH/LOT NUMBER OF THE PRODUCT. PROVIDED BATCH NUMBER #3360142 IS NOT MATCH WITH PROVIDED MATERIAL NUMBER#305781. 2. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. STAFF MEMBER RECEIVED A NEEDLE POKE TO THUMB WITH CONTAMINATED NEEDLE. 3. KINDLY CONFIRM ANY PHYSICAL SAMPLE OR PHOTO IF AVAILABLE FOR INVESTIGATION? IF YES, PLEASE PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? THE CONTAMINATED NEEDLE WAS DISPOSED OF IMMEDIATELY IN SHARPS CONTAINER. WE KNOW IF THIS IS TO OCCUR AGAIN THE NEEDLE WILL BE KEPT SO THAT IT CAN BE SHIPPED FOR FURTHER INVESTIGATION. PLEASE SEE THE ATTACHED PICTURE OF THE SAME BATCH OF NEEDLES. I AM NOT SURE WHERE TO ACCESS THE BATCH NUMBER SO I THOUGHT IT MIGHT BE EASY TO SEND YOU A PIC AS I SEE THERE IS A QR CODE ON THE PRODUCT THAT MIGHT PROVIDE YOU WITH MORE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1714151 BD NEEDLE ECLIPSE 25X5/8 HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 3360142 00382903057597

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown