MAUDE Adverse Event Report: EXCELSIOR MEDICAL EXCELSIOR MEDICAL

Lot Number 3126034

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2016

Event Type  malfunction  

Event Description

Rn grabbed a saline flush to clear a port and realized it was filled with 10ml of air with no saline.Mfr is excelsior medical lot 3126034, exp: 11/01/2017.The air did not reach the pt, no harm was done.

• Brand Name: EXCELSIOR MEDICAL
• Type of Device: EXCELSIOR MEDICAL
• Manufacturer (Section D): EXCELSIOR MEDICAL
• MDR Report Key: 5466496
• MDR Text Key: 39336128
• Report Number: MW5060575
• Device Sequence Number: 1
• Product Code: NGT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2017
• Device Lot Number: 3126034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1