MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION BURETROL SOLUTION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number ARC7503P

Device Problems Fluid/Blood Leak (1250); Fitting Problem (2183)

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

Event Date 12/06/2022

Event Type  malfunction  

Event Description

It was reported that the spike of a buretrol solution set did not fit with a non-baxter bag which caused the unspecified solution to leak.The issue was identified during patient use.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

The actual device was not available; however, a photograph of the sample was provided for evaluation.A visual inspection was performed to the photograph which did not identify any abnormalities that could have contributed to the reported condition.The reported condition is not clearly observed via the provided photographs and due to the nature of the returned sample no additional testing could be performed.Therefore, the reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: BURETROL SOLUTION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CALI; calle 36 no. 2c-22,; apartado aero 2446; cali ; CO
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16098049
• MDR Text Key: 308476262
• Report Number: 1416980-2022-07228
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412479484
• UDI-Public: (01)00085412479484
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

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: ARC7503P
• Device Lot Number: SE22HJ3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2022
• Initial Date FDA Received: 01/04/2023
• Supplement Dates Manufacturer Received: 02/05/2023
• Supplement Dates FDA Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/15/2022
• 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: LR FRESENIUS BAG