MAUDE Adverse Event Report: UNKNOWN IV DRIP; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Product Quality Problem (1506); Use of Device Problem (1670)

Patient Problem Malaise (2359)

Event Date 05/01/2022

Event Type  Injury  

Event Description

Hello.A mobile iv company ((b)(6)) is not operating with the proper 21 cfr registration and credentials.I used their services.I called to set up the appointment.They came to my work location during my lunch.Nothing was sanitary.She identified herself as a nurse but didn't show an id.She pulled out a previously used iv needle and attached it to a bag of liquid.While i was receiving the medicine, i started to feel sick.She stopped the drip and instructed me to put my head between my legs.Once i felt better, we continued.After it was done, she packaged the needle, the remainder of the liquid in the bag, and her supplies.I paid her and she left.My coworkers said this "ransaction" doesn't seem right.We are afraid they are going to severely injure or infect one of their unsuspecting patients.I feel so stupid for falling for this.I paid $(b)(6), didn't sign any "onsent" forms, didn't see clinical registration, and didn't even verify the nurse was actually a nurse.Paradigm companies.

• Brand Name: IV DRIP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 14633618
• MDR Text Key: 293711403
• Report Number: MW5110211
• Device Sequence Number: 1
• Product Code: FPA
• 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: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White