MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION IV TUBING AND DRIP CHAMBER; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 07062C7461

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Insufficient Information (4580)

Event Date 07/09/2021

Event Type  malfunction  

Event Description

Found brown tubing and some unknown substance in drip chamber.Supply chain discussed with the owens minor distributor who stated the discoloring was related to the post packaging sterilization.There was no comment regarding the black specs that were noted in the drip chamber.

• Brand Name: IV TUBING AND DRIP CHAMBER
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; one baxter parkway; deerfield IL 60015
• MDR Report Key: 12172915
• MDR Text Key: 261699845
• Report Number: 12172915
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/12/2021

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 Catalogue Number: 07062C7461
• Device Lot Number: SR21A07100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/12/2021
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/15/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1