MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION NORMAL SALINE; CONTAINER, I.V.

Lot Number G160629 (X3)

Device Problem Contamination (1120)

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

Event Date 02/10/2023

Event Type  malfunction  

Event Description

Baxter ns lot# g160629 (x3).Baxter ns lot# g160902 (x5).Baxter ns lot# g159647 (x1).Baxter sterile water lot# g161022, g159609, g160360.B.Braun ns lot# j2s947.Possible contaminates coming out of bottle.

• Brand Name: NORMAL SALINE
• Type of Device: CONTAINER, I.V.
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 25212 w. illinois route 120; round lake IL 60073
• MDR Report Key: 16724103
• MDR Text Key: 313138146
• Report Number: 16724103
• Device Sequence Number: 1
• Product Code: KPE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/10/2023,02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: G160629 (X3)
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/10/2023
• Date Report to Manufacturer: 04/12/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1