MAUDE Adverse Event Report: BAXTER HEALTHCARE - DOMINICAN REPUBLIC ACCESS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2H8865

Device Problems Fluid/Blood Leak (1250); Split (2537)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that the buretrol chamber of a clearlink non-dehp buretrol solution administration set was splitting open and leaking.This event occurred when the nurse was filling the buretrol with meropenem (non-baxter product) medication.There is no report of patient/user injury or medical intervention was needed in association with this event.No additional information is available.

Manufacturer Narrative

(b)(4).A batch review cannot be performed since there was no lot number provided.The sample was not returned for evaluation; therefore, a device analysis could not be performed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ACCESS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; carretera sanchez km 18.5; parque industrial itabo (piisa; haina san cristobal ; DR
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; carretera sanchez km 18.5; parque industrial itabo (piisa; haina san cristobal ; DR
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3727325
• MDR Text Key: 4328671
• Report Number: 1416980-2014-11019
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/10/2014

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: 2H8865
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2014
• Initial Date FDA Received: 04/04/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: MEROPENEM