MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION BAXTER EXACTAMIX INLET; SET, I.V. FLUID TRANSFER

Catalog Number H938173

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2020

Event Type  malfunction  

Event Description

Hair found in unopened sterile exactamix inlet tubing package from baxter.Fda safety report id # (b)(4).

• Brand Name: BAXTER EXACTAMIX INLET
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; chicago IL 60015
• MDR Report Key: 11100478
• MDR Text Key: 224869595
• Report Number: MW5098600
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): Y
• 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: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2023
• Device Catalogue Number: H938173
• Device Lot Number: 802992
• 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