MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; ADAPTER, TUBING, NUT, NIPPLE, OXYGEN, DISPOSABLE

Model Number 3280002555

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem Low Oxygen Saturation (2477)

Event Date 02/01/2017

Event Type  malfunction  

Event Description

Patient was connected to wall o2 unit while in diagnostic radiology.It was noted by staff that the patient's oxygen saturation had decreased so staff checked the flowmeter and found that the nipple adapter for the o2 was broken so the o2 was leaking and not reaching the patient.

• Type of Device: ADAPTER, TUBING, NUT, NIPPLE, OXYGEN, DISPOSABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 6390917
• MDR Text Key: 69463296
• Report Number: 6390917
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 3280002555
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/02/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 76 YR