MAUDE Adverse Event Report: VTM SAMPLING FLOCKED SWAB; APPLICATOR, ABSORBENT TIPPED, STERILE

Lot Number 202006

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem Insufficient Information (4580)

Event Date 02/18/2021

Event Type  malfunction  

Event Description

It was found while swabbing a patient that the wrong end of the swab is presented when the package is being opened.The handle end of the swab should be presented for the nurse to grab instead of the swab end.Incorrect packaging by the company.

• Brand Name: VTM SAMPLING FLOCKED SWAB
• Type of Device: APPLICATOR, ABSORBENT TIPPED, STERILE
• MDR Report Key: 11574484
• MDR Text Key: 242418505
• Report Number: 11574484
• Device Sequence Number: 1
• Product Code: KXG
• 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: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 202006
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/22/2021
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1