MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP PENDING; CANNULA,ADULT,SOFT-TOUCH,7TUBE,UC

Model Number	HCSU4514
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	10/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, the patient had been wearing the nasal cannula for 5 days when a 'right ear stage 3 pressure injury and left ear stage 2 pressure injury' was identified 'where the nasal cannula rests against the skin'.The customer reported wound care was consulted and the injury was treated with 'normal saline cleansing' and covered with 'hydrocolloid dressing'.According to the customer the patient 'was identified as high risk for hospital acquired pressure injury on admission'.The sample is not available to be returned for evaluation.No additional information is available at this time.Due to the reported incident and 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.
Event or Problem Description
According to the customer, the patient had been wearing the nasal cannula for 5 days when a 'right ear stage 3 pressure injury and left ear stage 2 pressure injury' was identified 'where the nasal cannula rests against the skin'.

• Brand Name: PENDING
• Common Device Name: CANNULA,ADULT,SOFT-TOUCH,7TUBE,UC
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15718066
• Report Number: 1417592-2022-00211
• Device Sequence Number: 16876612
• Product Code: CAT
• UDI-Device Identifier: 10884389966143
• UDI-Public: 10884389966143
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Report Date (Section B): 11/02/2022

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: HCSU4514
• Device Catalogue Number: HCSU4514
• Device Lot Number: 74922020004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 11/02/2022
• 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: Unknown