TOURNIQUET

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-27 for TOURNIQUET manufactured by Unknown.

Event Text Entries

[6196256] I had double hernia surgery. Surgery date was (b)(6) 2015: a brief synopsis of what happened. My friend (b)(6), drove me to the surgery center that morning. It took six (6) attempts (5 failed attempts) to insert an iv in my arm. The nurses were unprofessional and "made up" procedures as they went along with each failed iv attempt. These nurses were out of line with the incorrect information they were telling me as well as the "standard protocol" of inserting iv's per the hospitals standard of patient care. I tried to exercise my "patient rights" by helping them understand my veins so i could have a few sticks as possible in my arms. The end result of that day was that i being bullied, manipulated and intimidated by those nurses. I felt as though i was being punished based upon how i was being poked and the things i was being told by each nurse. The first 2 sticks were in my left arm and caused immediate bruising and pain. My vein has phlebitis and the bruising and pain was still there 14 days post surgery; and now 6 weeks post surgery. The first nurse said after the first stick she didn't get it because my vein rolled. She immediately stuck me in the same spot again and pulled out the needle and said "now that i've got my two sticks in, i can get someone else in here to start your iv. " the 2nd nurse tried on the right arm and was unsuccessful. She said that she would not try again and called in a 3rd nurse. I asked if my friend could come into the room with me. The nurse said yes, we will get her. Nurse #3, (b)(6), comes in. She took my arm and looked at my veins. She said that she would need to put a tourniquet on me very very tight so she could "see" them bulge and she could get to a deeper vein. I told her i did not want the tourniquet on my arm that tight that it could cut off the flow of blood and she would infiltrate my vein if she did this. She was annoyed that i said this to her and she told me to let her "do her job". I said again, i'm exercising my patient rights by asking you please do not put the tourniquet on my arm tightly. I had already had 3 failed iv attempts and i did not want a 4th. The nurse put on the iv so tight that i began to cry and ask her to please remove it. I looked at my friend (b)(6) (she's nurse also) and asked her if she could possibly find a vein that this nurse could stick. (b)(6) began to feel of my right arm and the nurse told her to get back to the other side of the bed and that she was the nurse and she had been doing this for quite some time. She also said "i know it seems archaic to use a tourniquet to find a vein, but i've been on the other side as a patient and it usually takes 3-4 sticks to get an iv in your arm. Now, let me do my job or i will postpone your surgery to another date. " she took a blue hairnet (kind you wear in surgery) and put it on my arm. She then took the tourniquet and stretched it over my arm so tightly that it became numb immediately. She inserted the iv and it didn't take. She pulled it out and inserted it again (now stick #5) and left it in my arm. My arm had numbness and pain and it began to swell up. She had infiltrated my vein and the fluids were going into my arm and not into the intended vein. I asked her to get it out and she insisted that it was "fine" and left it in my arm and walked out of the room. A nurse came in and took it out and said they would call in anesthesiology to insert the iv as my arm was swelling and had immediate bruising. Iv attempt #6 was in my wrist and worked.. It has been 6 weeks post-op and i have still having pain in my right arm. I have two knots (hematoma's from the rupture) under the skin and have tingling, numbness and some shooting pains down my arm. I am not able to use my right hand to hold something for an extended period of time. The medical device (the tourniquet) certainly played an intricate role in the injuries of my veins, along with nurses not using the who standard procedures properly when trying a tourniquet.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5044907
MDR Report Key4953130
Date Received2015-07-27
Date of Report2015-07-24
Date of Event2015-06-02
Date Added to Maude2015-07-31
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameTOURNIQUET
Generic NameTOURNIQUET
Product CodeGAX
Date Received2015-07-27
OperatorHEALTH PROFESSIONAL
Device Sequence No1
Device Event Key0
ManufacturerUNKNOWN


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-07-27

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