MAUDE Adverse Event Report: MEDICAL ACTION INDUSTRIES INC. 306 MEDICAL ACTION INDUSTRIES; CENTRAL VENOUS CATHETER DRESSING CHANGE KIT

Model Number 77433

Device Problems Component Missing (2306); Material Integrity Problem (2978)

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

Event Date 08/14/2019

Event Type  malfunction  

Event Description

Medical action industries inc.Cvc redress kit red #77433, lot#260139, exp 01-31-2021.Cvc redress kit did not have a biobatch, sterile gloves were abnormally thin and easy to rip, and chlora-prep swabs were dry.

• Brand Name: MEDICAL ACTION INDUSTRIES
• Type of Device: CENTRAL VENOUS CATHETER DRESSING CHANGE KIT
• Manufacturer (Section D): MEDICAL ACTION INDUSTRIES INC. 306; 25 heywood rd.; arden NC 28704
• MDR Report Key: 8990725
• MDR Text Key: 157475622
• Report Number: 8990725
• Device Sequence Number: 1
• Product Code: PEZ
• 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: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 77433
• Device Catalogue Number: 77433
• Device Lot Number: 260139
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/21/2019
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/11/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1