MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ALL-IN-ONE CONTAINER; CONTAINER, I.V.

Catalog Number DSB8134

Device Problem Contamination (1120)

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

Event Date 12/23/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter postal code - (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a 3-lead 3l bag was contaminated on one of the spikes.The contamination was not further described.This issue was identified after opening the packaging before patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: upon further investigation, it was determined that this report is a duplicate of manufacturers report # 1416980-2021-07907.All investigation activities will be captured under mfg.Report # 1416980-2021-07907.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ALL-IN-ONE CONTAINER
• Type of Device: CONTAINER, I.V.
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - TUNISIA; route de chebbaou; 2021oued e; tunis ; TS
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 13508344
• MDR Text Key: 285529390
• Report Number: 1416980-2022-00465
• Device Sequence Number: 1
• Product Code: KPE
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: DSB8134
• Device Lot Number: 21C29T686
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/24/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NA.