BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1 RB

    MDR report key: 19968302 · Received August 12, 2024

    Report

    Report Number
    1911916-2024-00584
    Event Type
    Malfunction
    Date Received
    August 12, 2024
    Date of Event
    July 25, 2024
    Report Date
    August 20, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051954
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION: IT WAS REPORTED THERE WAS EXCESSIVE RESIDUE OF GLUE ON THE HUB. TO AID IN THE INVESTIGATION, EIGHT SAMPLES WITH NO PACKAGING BLISTERS AND ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE SAMPLES WERE ACCEPTABLE ACCORDING TO PRODUCT SPECIFICATIONS. THE PHOTO PROVIDED SHOWS THE SAMPLES RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305195, LOT 4150728. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN THIS FORMAT DD-MMM-YYYY? PRODUCT WAS RECEIVED 25/07/2024, DEFECTIVE PRODUCT WAS FOUND THE SAME DAY. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. THIS WAS FOUND ON OUR INCOMING AREA. THEREFORE, IT WAS NEVER USED IN A PATIENT. MATERIAL # 305195; BATCH # 4150728. IT WAS REPORTED BY CUSTOMER THAT PRODUCT HAS EXCESSIVE RESIDUE OF GLUE ON THE HUB. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PRODUCT 305195 HAS BEEN REJECTED IN OUR INCOMING RECEIVING AREA BY OUR QUALITY TEAM FOR THE BELOW REASON: PRODUCT HAS EXCESSIVE RESIDUE OF GLUE ON THE HUB. SAMPLES AVAILABLE. BUSSE ITEM# 8080A-1. BD ITEM# 305195- 18 GAUGE X 1" NEEDLE. LOT# 4150728. (B)(4). QTY REJECTED 2 CASES (B)(4) PCS.

    Description of Event or Problem · 0

    MATERIAL # 305195 BATCH # 4150728. IT WAS REPORTED BY CUSTOMER THAT PRODUCT HAS EXCESSIVE RESIDUE OF GLUE ON THE HUB. RCC RECEIVED A COMPLAINT VIA EMAIL. PRODUCT 305195 HAS BEEN REJECTED IN OUR INCOMING RECEIVING AREA BY OUR QUALITY TEAM FOR THE BELOW REASON: PRODUCT HAS EXCESSIVE RESIDUE OF GLUE ON THE HUB -SEE PICTURE ATTACHED, SAMPLES AVAILABLE. BUSSE ITEM# 8080A-1. BD ITEM# 305195- 18 GAUGE X 1" NEEDLE. LOT# 4150728. PO (B)(4). QTY REJECTED (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2485945 NEEDLE 18X1 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 4150728 30382903051954

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown