MAUDE Adverse Event Report: METREX RESEARCH CAVIWIPES1; GERMICIDAL WIPES

Model Number 13-5100

Device Problems Break (1069); Device Packaging Compromised (2916); Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/16/2017

Event Type  malfunction  

Event Description

Employee was opening a new container of caviwipes 1, when she broke the seal there was a foreign object.It appears to be metal with rust around it.Package was completely sealed.

• Brand Name: CAVIWIPES1
• Type of Device: GERMICIDAL WIPES
• Manufacturer (Section D): METREX RESEARCH
• MDR Report Key: 6964347
• MDR Text Key: 90032797
• Report Number: MW5072847
• Device Sequence Number: 1
• Product Code: LRJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2019
• Device Model Number: 13-5100
• Device Lot Number: 17-1003PA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1