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

Model Number 71591

Device Problem Component Missing (2306)

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

Event Date 10/29/2018

Event Type  malfunction  

Event Description

Swab pad was missing in multiple iv start kits recently.The kits had the liquid from the pad in the kit but no pad.

• 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: 8068563
• MDR Text Key: 127117568
• Report Number: 8068563
• Device Sequence Number: 1
• Product Code: LRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 71591
• Device Catalogue Number: 71591
• Device Lot Number: 250056
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/29/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1