MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; TRAY,TRACH,MINI,NO GLOVES,NONSTERILE

Model Number	DYND40622
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer, she noticed damage to the inside of her tracheostomy tube, she reports "the metal damaged the inside trach and split it apart." according to the customer, over time the brush caused this to occur because they are "hard and not flexible." she reports due to this, she will need to have the tube replaced by her doctor.Customer reports she uses the brushes one time and then disposes of them.The sample has been requested to be returned for evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
Damage to trach requiring tube to be replaced.
Additional Manufacturer Narrative
According to the customer, she noticed damage to the inside of her tracheostomy tube, she reports "the metal damaged the inside trach and split it apart".According to the customer, over time the brush has caused this to occur because they are "hard and not flexible".She reports due to this, she will need to have the tube replaced by her doctor.Customer reports she uses the brushes one time and then disposes of them.A sample was requested to be returned for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: MEDLINE
• Common Device Name: TRAY,TRACH,MINI,NO GLOVES,NONSTERILE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16313612
• Report Number: 1417592-2023-00045
• Device Sequence Number: 5708673
• Product Code: OGV
• UDI-Device Identifier: 10080196032914
• UDI-Public: 10080196032914
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2024

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?: No
• Device Model Number: DYND40622
• Device Catalogue Number: DYND40622
• Device Lot Number: 10-6052208009
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2023
• Supplement Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female