MAUDE Adverse Event Report: UNKNOWN PISTON PLASTIC SYRINGE LIDOCAINE HCL 2% (URO-JET) REGULATION NO. 880.5860; SYRINGE, PISTON

Model Number 76329-3011-5, 76329-3012-5,

Patient Problems Emotional Changes (1831); Hemorrhage/Bleeding (1888); Pain (1994); Unspecified Heart Problem (4454)

Event Date 02/28/2022

Event Type  Injury  

Event Description

This pt (patient) had rectal surgery fulguration resulting in complications that lead to ambulance er care.Uncontrolled bleeding and pain.In er (emergency room) exam dr.(b)(6) unable to complete dre (digital rectal exam) sought other method returning to pt room with instrument later id as ims piston syringe lidocaine hcl 2%.The va (veterans affair) (b)(6) doctor then attempted to internally insert and inject the regulated medication by non-prescribed method of manufacturer (whom i later called) the piston device felt sharp and ragged like it was cutting me inside the rectum during the insertion causing severe pain to point student trainee came around bed asking me to squeeze her hand.I only wanted the device removed and procedure stopped.Insistent 3-4 times to stop and being told just bare it.I at discharge obtained the bedside device and once home, i researched manufacturer insert on fda website that stated intended for external use only, in urethra (male/ female) not intended in rectal/rectum exam.I there after developed heart issues and ptsd (post-traumatic stress disorder) nightmare from what clinical psychiatrist states is sexual trauma ptsd.The use of the class ii device, and after examining the plastic uro-jet syringe, it was found to have had raised plastic edges from injected molded process that were not addressed in quality control and are more than likely why felt like cutting inside of my rectum from jagged edges.The devices is not the real issue because it was never intended to be full inserted internally, only the tip is prescribed to be used which medical practitioner violated regulatory fda prescribed use.The manufacturer emailed me its recommended use documents after speaking on the phone with (b)(4).And (b)(4) @ 11:43 am, on the phone insisting this was improper use by doctor and against the insert material and recommend use.The id on the lidocaine reflects (b)(4) lidocaine hydrochloride jelly usp, 2% a sterile, water-soluble, topical anesthetic.And bar code (b)(4), (b)(4) (100 mg and rx only).Va indicates no rx (prescription) was need as the medication is readily available in er station.Reported complaint to privacy manger, er manager and the va chief of staff as well as (b)(6).The va investigation into use of the device claims the device and plunger are not rx regulated for disbursement in er setting and was never ordered from hospital pharmacy by the doctor performing anal exam ((b)(6) stated).This too would violate fda policy and printed label for rx use of a regulated class ii agent lidocaine hcl 2%.To be dispensed on a order of license professional cfr 801.109 (b)(1) i also have the communication from the va investigator whom i complained to about improper use.It should also be noted the (b)(6) license board has begun proceedings against the doctor for the complained of use and refusal to adhere to patient rights to not have procedure begun/continued and u.S.Patient bill of rights.

• Brand Name: PISTON PLASTIC SYRINGE LIDOCAINE HCL 2% (URO-JET) REGULATION NO. 880.5860
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18960435
• MDR Text Key: 338494635
• Report Number: MW5153066
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2024
• Device Model Number: 76329-3011-5, 76329-3012-5,
• Device Catalogue Number: 7630120H 7-11
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: LIDOCAINE HCL 2%.
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American