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

Model Number SW0102

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/01/2021

Event Type  malfunction  

Event Description

Typenex medical specimen collection swabs (product code: sw0102, lot 080320) 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 emergency department to remove the swab tip from their nostril.

• Brand Name: SPECIMEN COLLECTION SWAB / NASOPHARYNGEAL
• Type of Device: APPLICATOR, ABSORBENT TIP, STERILE
• Manufacturer (Section D): TYPENEX MEDICAL, LLC; 303 e. wacker dr.; suite 1030; chicago IL 60601
• Manufacturer (Section G): GOODWOOD MEDICAL CARE LTD.; 1-2 floor, 3-919 yongzheng str; jinzhou district; dalian, liaoning province 11610 0; CH 116100
• Manufacturer Contact: michael choquette ; 303 e. wacker drive; suite 1030; chicago, IL 60601 ; 3128884064
• MDR Report Key: 11378450
• MDR Text Key: 269426914
• Report Number: 3005720829-2021-00601
• Device Sequence Number: 1
• Product Code: KXG
• UDI-Device Identifier: 00810050851909
• UDI-Public: (01)00810050851909
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA#S-P#NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention