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

Catalog Number 2C7557

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Chemical Spillage (2894)

Patient Problem No Patient Involvement (2645)

Event Date 03/25/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A batch review was conducted and revealed that all of the acceptance criteria were met to release the lot.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.

Event Description

It was reported that the spike of a vented paclitaxel set "'fell out¿ of the bottle while still in the pharmacy." the reporter stated that this led to a spill of an unknown chemotherapeutic drug.This occurred during set-up, before patient use.There was no patient involvement.No additional information is available.

• Brand Name: ACCESS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE; 600 mts oeste de entrada; cartago ; CS
• Manufacturer (Section G): BAXTER HEALTHCARE; 600 mts oeste de entrada; cartago ; CS
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3758767
• MDR Text Key: 15882550
• Report Number: 1416980-2014-12568
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981792
• 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: 03/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2018
• Device Catalogue Number: 2C7557
• Device Lot Number: R13K18104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2014
• Date Device Manufactured: 11/19/2013
• 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