MAUDE Adverse Event Report: COPAN ITALIA FLOQ SWABS; APPLICATOR, ABSORBENT TIPPED, NON-STERILE

Model Number XA5S108B01

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/09/2020

Event Type  malfunction  

Event Description

Copan floqswabs, during an attempt to collect a culture on a patient for covid-19, the tip of the pcr swab that was used (about 4.5cm) broke off and it got stuck in the nasopharyngeal cavity.Fda safety report id# (b)(4).

• Brand Name: FLOQ SWABS
• Type of Device: APPLICATOR, ABSORBENT TIPPED, NON-STERILE
• Manufacturer (Section D): COPAN ITALIA
• MDR Report Key: 10082270
• MDR Text Key: 191983188
• Report Number: MW5094632
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/19/2020

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: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: XA5S108B01
• Device Lot Number: 1919615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/21/2020
• 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
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Weight: 77