MAUDE Adverse Event Report: BAXTER HEALTHCARE - AIBONITO 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 Date 03/09/2014

Event Type  malfunction  

Event Description

It was reported that the buretrol chamber of a clearlink non-dehp buretrol solution set was splitting open and leaking during priming of the set with meropenem (non-baxter product).The nurse also reported "when she held it in her hand the buretrol material felt harder than usual." 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 discarded by the customer.Therefore, no analysis can 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 - AIBONITO; rd 721 km 0 3 po box 1389; aibonito PR 705
• Manufacturer (Section G): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3 po box 1389; aibonito PR 705
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3722310
• MDR Text Key: 4306620
• Report Number: 1416980-2014-10783
• 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: 04/02/2014
• 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