BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 RB

    MDR report key: 18076134 · Received November 6, 2023

    Report

    Report Number
    1911916-2023-00823
    Event Type
    Malfunction
    Date Received
    November 6, 2023
    Date of Event
    October 25, 2023
    Report Date
    November 10, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051961
    PMA / PMN Number
    K021475
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305196 AND LOT NUMBER 3024115. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. H3 OTHER TEXT : SEE H10 NARRATIVE

    Additional Manufacturer Narrative · 0

    (B)(6): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. PATIENT PROBLEM CODE: F27 ¿ NO PATIENT INVOLVEMENT. DEVICE PROBLEM CODE: A0201 - PRODUCT QUALITY PROBLEM.

    Description of Event or Problem · 0

    PR 9163544 ADDITIONAL INFORMATION RECEIVED MAT#: 305196 BATCH#: 3024115 IT WAS REPORTED BY CUSTOMER THAT WHITE RESIDUE AROUND THE AREA WHERE THE PLASTIC AND THE NEEDLE JOIN AND DRIPS OF WHITE RESIDUE ON THE NEEDLE ITSELF. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. REPORTED ISSUE: WHITE RESIDUE AROUND THE AREA WHERE THE PLASTIC AND THE NEEDLE JOIN AND DRIPS OF WHITE RESIDUE ON THE NEEDLE ITSELF. ITEM: 305196 QUANTITY AFFECTED: 6 BOXES SERIAL/LOT NUMBER: (B)(6) PO : (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES (B)(6)2023 - DATE OF EVENT: 10/25/23 - ARE YOU ABLE TO PROVIDE THE PHOTO OF THE SAMPLES? PLEASE ATTACH IN THIS EMAIL. NO, NEEDLE WAS THROWN OUT AND NO PHOTO TAKEN - ARE YOU ABLE TO CONFIRM IF THE EPOXY THAT HOLDS THE NEEDLE ON THE HUB IS EXCESSIVE ON THE NEEDLE HUB OR IT IS NORMAL AMOUNT? IT DID NOT SEEM EXCESSIVE, JUST THAT SOME DRIPPED DOWN THE NEEDLE BEFORE IT HAD DRIED - MAY I KNOW IF YOU ARE AWARE THAT THERE IS WHITE EPOXY THAT HOLDS THE NEEDLE TO THE NEEDLE HUB? YES, AWARE WHAT HOLDS THE NEEDLE TO THE HUB. (B)(6)2023 WE DO NOT HAVE A SAMPLE AVAILABLE BECAUSE THE TECHNOLOGIST DISPOSED OF IT ONCE SHE OPENED IT. SHE REPORTED IT TO OUR MANAGEMENT TEAM AND PULLED THE REST OF THE BOXES THAT WE HAD WITH THAT LOT #.

    Description of Event or Problem · 0

    MAT#: 305196. BATCH#: 3024115. IT WAS REPORTED BY CUSTOMER THAT WHITE RESIDUE AROUND THE AREA WHERE THE PLASTIC AND THE NEEDLE JOIN AND DRIPS OF WHITE RESIDUE ON THE NEEDLE ITSELF. ARE ANY SAMPLES AVAILABLE FOR RETURN? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337823 NEEDLE 18X1-1/2 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 3024115 30382903051961

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown