MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION MICRO-VOLUME EXTENSION SET; FILTER, INFUSION LINE

Catalog Number 2N3350

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Event Description

It was reported that the filter of the non-dehp micro-volume extension set cracked on the bonded side where the tubing connects to the filter which resulted in a leak out of the air vent.The extension set was used with a non-baxter syringe pump and lorazepam.This was discovered during priming.There was no patient involvement.No additional information is available.

Manufacturer Narrative

B3: event date: (b)(6)2023.Initial reporter (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: MICRO-VOLUME EXTENSION SET
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; carretera sanchez km 18.5; parque industrial itabo, piisa; haina, san cristobal 91000 ; DR 91000
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 17378859
• MDR Text Key: 319930304
• Report Number: 1416980-2023-03736
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113227
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2N3350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2023
• 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: ATIVAN (LORAZEPAM); MEDFUSION SYRINGE PUMP