MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY ALARIS; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2017

Event Type  malfunction  

Event Description

After line change, the alaris pump continued to ring off that the uac was occluded to patient.All connections were correct.Two other nurses checked to make sure all connections were open and patent for uac.Practitioner was aware.Ended up having to break into line again sterile.Patient was not injured in anyway.

• Brand Name: ALARIS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th ave; columbus NE 68601
• MDR Report Key: 7103936
• MDR Text Key: 94374743
• Report Number: 7103936
• Device Sequence Number: 1
• Product Code: FPA
• 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: 10/18/2017,11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/18/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2017
• 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
• Treatment: NO