MAUDE Adverse Event Report: MEDICAL ACTION INDUSTRIES, INC. MEDICAL ACTION INDUSTRIES; I.V. START KIT

Model Number 267014

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/24/2018

Event Type  malfunction  

Event Description

Sterility issue: nurse was getting ready to start iv, looked at iv start kit pulled from supply cart, and he noticed a hair that is sealed in package.Iv start kit was not opened and taken to quality office.

• Brand Name: MEDICAL ACTION INDUSTRIES
• Type of Device: I.V. START KIT
• Manufacturer (Section D): MEDICAL ACTION INDUSTRIES, INC.; 25 heywood rd.; arden NC 28704
• MDR Report Key: 7792898
• MDR Text Key: 117476307
• Report Number: 7792898
• Device Sequence Number: 1
• Product Code: LRS
• UDI-Device Identifier: 10809160004999
• UDI-Public: (01)10809160004999(17)210131(10)247027
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 267014
• Device Lot Number: 247027
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/07/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/17/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1