MAUDE Adverse Event Report: C. R. BARD POWER LOC MAX REF 0142075; SET, ADMINISTRATION INTRAVASCULAR

Device Problem Disconnection (1171)

Patient Problem No Code Available (3191)

Event Date 07/13/2018

Event Type  malfunction  

Event Description

Cadd extension set from smiths medical (b)(4) is connected to power loc max ref 142075.The connection between these two products has always been tight, but the last few months we have had several pts where they have become disconnected while receiving infusional 5fu resulting in a split.

• Brand Name: POWER LOC MAX REF 0142075
• Type of Device: SET, ADMINISTRATION INTRAVASCULAR
• Manufacturer (Section D): C. R. BARD
• MDR Report Key: 7697689
• MDR Text Key: 114430691
• Report Number: MW5078446
• 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: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 07/13/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1