MAUDE Adverse Event Report: DALIAN GOODWOOD MEDICAL CARE LTD MCKESSON BRANDS; APPLICATOR, COTTONTIP STR 6"

Catalog Number 24-106-2S

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/20/2021

Event Type  Injury  

Event Description

It was reported that the patient was cleaning her tracheostomy tube with a cotton tipped applicator that broke during use resulting in an emergency room visit.The patient was admitted and a fiberoptic bronchoscopy procedure was performed to remove the broken piece of the applicator on (b)(6) 2021.

• Brand Name: MCKESSON BRANDS
• Type of Device: APPLICATOR, COTTONTIP STR 6"
• Manufacturer (Section D): DALIAN GOODWOOD MEDICAL CARE LTD; 3-91 jiulicun yongzheng street; jinzhou district, dalian 11600 1; CH 116001
• MDR Report Key: 14685463
• MDR Text Key: 294882980
• Report Number: 1451040-2022-00024
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 24-106-2S
• Device Lot Number: CGJ02-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/14/2022
• Distributor Facility Aware Date: 05/18/2022
• Device Age: 26 MO
• Event Location: Home
• Date Report to Manufacturer: 06/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization