MAUDE Adverse Event Report: BD ALARIS PUMP TUBING; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2420-0007

Device Problem Contamination (1120)

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

Event Date 08/20/2022

Event Type  malfunction  

Event Description

This reporter began to hang some iv fluids for this newly admitted patient, but noticed in the piv tubing chamber a possible oily solution.The tubing is ref 2420-0007.Tubing left at charge nurse desk for risk management to pick up on monday to assess.Grabbed a different piv tubing set to administer fluids to the patient.Fda safety report id (b)(4).

• Brand Name: ALARIS PUMP TUBING
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD; franklin lakes CO 07417
• MDR Report Key: 15322176
• MDR Text Key: 299044984
• Report Number: MW5111794
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: (10)22065395
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male