BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 BLUNT FILL

    MDR report key: 18236625 · Received November 30, 2023

    Report

    Report Number
    1911916-2023-00870
    Event Type
    Malfunction
    Date Received
    November 30, 2023
    Date of Event
    September 16, 2023
    Report Date
    December 15, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    GAA
    UDI-DI
    30382903051800
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) 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: A140902 - PARTIAL BLOCKAGE.

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305180 AND LOT NUMBER 3024127. 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.

    Description of Event or Problem · 0

    THIS MDR REFLECTS THE MD'S ISSUE MATERIAL #: 305180 BATCH#: 3024127 IT WAS REPORTED BY CUSTOMER THAT BLUNT FILL NEEDLES BY BD ARE HAVING ISSUE OF NOT PULLING UP ENOUGH FLUID. REGISTERED NURSE (RN) WAS PULLING UP AMP FOR A PATIENT AND WHEN RN WENT TO GO DRAW THE AMP UP, RN WAS SHORT. RN NOTICED THAT AFTER PUTTING THE STERILE WATER INTO THE AMP THERE WAS A LOT OF PRESSURE AND SPRAYING OF THE STERILE WATER. TODAY WHILE MD WAS DRAWING UP LIDOCAINE FOR CIRCUMCISION PROCEDURE, MD STATED IT WAS DIFFICULT TO PULL THE SOLUTION FROM THE VIAL USING THAT NEEDLE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. DESCRIBE THE EVENT OR PROBLEM: SITUATION: BLUNT FILL NEEDLES BY BD ARE HAVING ISSUE OF NOT PULLING UP ENOUGH FLUID. BACKGROUND: REGISTERED NURSE (RN) WAS PULLING UP AMP FOR A PATIENT AND WHEN RN WENT TO GO DRAW THE AMP UP, RN WAS SHORT. RN NOTICED THAT AFTER PUTTING THE STERILE WATER INTO THE AMP THERE WAS A LOT OF PRESSURE AND SPRAYING OF THE STERILE WATER. TODAY WHILE MD WAS DRAWING UP LIDOCAINE FOR CIRCUMCISION PROCEDURE, MD STATED IT WAS DIFFICULT TO PULL THE SOLUTION FROM THE VIAL USING THAT NEEDLE. ASSESSMENT: NEW REVISION OF BD NEEDLES ARE DEFECTIVE OR NOT OF QUALITY. RECOMMENDATION: NEW BRAND. KNOW WE CARRIED THIS BRAND BEFORE AND IT WAS NOT A PROBLEM SO MAY BE THE LOT. NO PATIENT HARM IN THIS EVENT, MEETING RESISTANCE WHEN DRAWING UP FLUIDS WITH THE BLUNT TIP NEEDLE FROM VIALS. THE PRODUCT INVOLVED WAS DISPOSED. MODEL # 305180 LOT # 3024127 DATE OF EVENT: 16 SEP 2023 PATIENT INFO: AGE: 2 DAYS SEX: MALE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED MATERIAL #: 305180 BATCH#: 3024127. IT WAS REPORTED BY CUSTOMER THAT BLUNT FILL NEEDLES BY BD ARE HAVING ISSUE OF NOT PULLING UP ENOUGH FLUID. REGISTERED NURSE (RN) WAS PULLING UP AMP FOR A PATIENT AND WHEN RN WENT TO GO DRAW THE AMP UP, RN WAS SHORT. RN NOTICED THAT AFTER PUTTING THE STERILE WATER INTO THE AMP THERE WAS A LOT OF PRESSURE AND SPRAYING OF THE STERILE WATER. TODAY WHILE MD WAS DRAWING UP LIDOCAINE FOR CIRCUMCISION PROCEDURE, MD STATED IT WAS DIFFICULT TO PULL THE SOLUTION FROM THE VIAL USING THAT NEEDLE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. DESCRIBE THE EVENT OR PROBLEM: SITUATION: BLUNT FILL NEEDLES BY BD ARE HAVING ISSUE OF NOT PULLING UP ENOUGH FLUID. BACKGROUND: REGISTERED NURSE (RN) WAS PULLING UP AMP FOR A PATIENT AND WHEN RN WENT TO GO DRAW THE AMP UP, RN WAS SHORT. RN NOTICED THAT AFTER PUTTING THE STERILE WATER INTO THE AMP THERE WAS A LOT OF PRESSURE AND SPRAYING OF THE STERILE WATER. TODAY WHILE MD WAS DRAWING UP LIDOCAINE FOR CIRCUMCISION PROCEDURE, MD STATED IT WAS DIFFICULT TO PULL THE SOLUTION FROM THE VIAL USING THAT NEEDLE. ASSESSMENT: NEW REVISION OF BD NEEDLES ARE DEFECTIVE OR NOT OF QUALITY. RECOMMENDATION: NEW BRAND. KNOW WE CARRIED THIS BRAND BEFORE AND IT WAS NOT A PROBLEM SO MAY BE THE LOT. NO PATIENT HARM IN THIS EVENT, MEETING RESISTANCE WHEN DRAWING UP FLUIDS WITH THE BLUNT TIP NEEDLE FROM VIALS. THE PRODUCT INVOLVED WAS DISPOSED. MODEL # 305180 LOT # 3024127. DATE OF EVENT: 16 SEP 2023. PATIENT INFO: AGE: 2 DAYS SEX: MALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1771993 NEEDLE 18X1-1/2 BLUNT FILL NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BECTON DICKINSON 3024127 30382903051800

    Patients

    Seq Age Sex Outcome Treatment
    1 Male