MAUDE Adverse Event Report: BXTER HEALTHCARE CORPORATION STERILE REPEATER PUMP FLUID TRANSFER TUBE SET; SYSTEM, DEVICE, PHARMACY COMPOUNDING

Lot Number 60147049

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2019

Event Type  malfunction  

Event Description

There is hair inside a sterile packaging of baxter repeater pump tubing.Fda safety report id# (b)(4).

• Brand Name: STERILE REPEATER PUMP FLUID TRANSFER TUBE SET
• Type of Device: SYSTEM, DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BXTER HEALTHCARE CORPORATION
• MDR Report Key: 8744180
• MDR Text Key: 149676136
• Report Number: MW5087684
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 60147049
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/27/2019
• 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