MAUDE Adverse Event Report: BAXTER HEALTHCARE CORP. EXTENSION TUBING; SET ADMINISTRATION, INTRAVASCULAR

Device Problem Material Discolored (1170)

Patient Problem Discomfort (2330)

Event Type  malfunction  

Event Description

Spoke to pt, she claims the tubings she received in last shipment were brown in color instead of clear.She is worried they are old or damaged in some way and does not feel comfortable using them (patient did not use any of them) patient is not home therefore does not have the lot number to these tubing¿s available, but informed her to hold on to the packages.The manufacturer will probably ask for the lot number later and may even want the defective tubing¿s returned, so asked her not to throw them away.No further information is known.Dates of use: from (b)(6) 2015 to ongoing.Diagnosis or reason for use: pah.

• Brand Name: EXTENSION TUBING
• Type of Device: SET ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORP.
• MDR Report Key: 7934113
• MDR Text Key: 123069077
• Report Number: MW5080338
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1