MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CANNULA,ADULT,SOFT-TOUCH,7'TUBE,UC

Catalog Number	HCSU4514
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that while a hospice patient was at her daughter's home, patient was getting out of bed to use the restroom and patient tangled up in the 25 feet oxygen tubing connector and 7 feet nasal cannula.The oxygen tubing connector and nasal cannula were reportedly connected to an oxygen concentrator at the time of the incident.No information was provided related to the required level of assistance for patient to safely get out of bed and ambulate.Reportedly, the patient called out for her daughter and daughter found patient on her right side on the floor.The patient's daughter called emergency medical services, which transported patient to local emergency department for evaluation and treatment.This revealed that patient sustained right patellar fracture.The patient was reportedly discharged from the hospital and remains under the services of the reporting facility (hospice/palliative), "non-seeking of aggressive treatment at this time".Patient is taking percocet 5/325 mg every 4 hours as needed for pain.Of note, it was reported that there were no known manufacturing or design issues specific to the nasal cannula or oxygen connector, which could have caused the reported incident.Due to the reported event and the patellar fracture, this medwatch is being filed.The sample is not available to be returned for evaluation.Unintended use error could have caused or contributed to the event.A definitive root cause could not be established at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that patient tangled up in the 25 feet oxygen tubing connector and 7 feet nasal cannula.Patient sustained right patellar fracture.

• Common Device Name: CANNULA,ADULT,SOFT-TOUCH,7'TUBE,UC
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8915387
• Report Number: 1417592-2019-00138
• Device Sequence Number: 16272099
• Product Code: CAT
• UDI-Device Identifier: 10884389966143
• UDI-Public: 10884389966143
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (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): 08/21/2019

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: Lay User/Patient
• Device Catalogue Number: HCSU4514
• Device Lot Number: 49118120005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 08/21/2019
• 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
• Patient Age: 64 YR
• Patient Weight: 71