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

Catalog Number VMC9694

Device Problem Component Missing (2306)

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

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that two (2) units of buretrol sol.Admin.Sets had the ¿air vent tubing is missing¿.This issue was identified in the hospital ward before use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: device manufactured in october 2021.H10: the actual device was not available; however, five (5) photograph of the sample were provided for evaluation. a visual inspection was performed to the photographs using the naked eye which revealed that that the injection site was missing from the burette.The reported condition was verified.By the nature of the sample, no additional tests were performed.The cause of the reported condition was a manufacturing issue.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Upon further review, it was determined that the missing component would prevent the user fromusing the product altogether, this may lead to a slight delay in therapy but is unlikely to cause harm to the patient.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 - TUNISIA; route de chebbaou; 2021oued e; tunis ; TS
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15658930
• MDR Text Key: 304825456
• Report Number: 1416980-2022-05665
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05413760272573
• UDI-Public: (01)05413760272573
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: VMC9694
• Device Lot Number: 21J28T090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: No
• 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