MAUDE Adverse Event Report: TYPENEX MEDICAL, LLC SPECIMEN COLLECTION SWAB / NASOPHARYNGEAL; APPLICATOR, ABSORBENT TIPPED, STERILE

Model Number	SW0102
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
"investigation memo for complaint (b)(4).".
Event or Problem Description
Typenex medical specimen collection swabs (product code: sw0102, lot 08032) broke off within the patient's nostril during sample collection.The swab broke at the designated break point, that is the point on the swab that is intended to break inside the viral transport tube in order to leave the flocked head inside the tube and allow the tube to be capped for transport.The patient received additional medical attention at a local outpatient care facility to remove the swab tip from their nostril.A similar issue with a different patient has already been reported that occurred on the same day and at the same hospital.

• Brand Name: SPECIMEN COLLECTION SWAB / NASOPHARYNGEAL
• Common Device Name: APPLICATOR, ABSORBENT TIPPED, STERILE
• Manufacturer (Section D): TYPENEX MEDICAL, LLC; 303 e. wacker drive; suite 1030; chicago IL 60601
• MDR Report Key: 11378456
• Report Number: 3005720829-2021-01201
• Device Sequence Number: 19852850
• Product Code: KXG
• UDI-Device Identifier: 00810050851909
• UDI-Public: (01)00810050851909
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: NA#S-P#NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/02/2023
• Device Model Number: SW0102
• Device Catalogue Number: SW0102
• Device Lot Number: 080320
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention