MAUDE Adverse Event Report: BAXTER HEALTHCARE - CALI ACCESS; STOPCOCK, I.V. SET

Catalog Number ARC2220P

Device Problems Fluid/Blood Leak (1250); Device Inoperable (1663)

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

Event Date 03/28/2014

Event Type  malfunction  

Event Description

It was reported that a three way stopcock leaked.This malfunction occurred during infusion on a patient.There was no report of patient injury, medical intervention, or adverse event in association with this event.No additional information is available.

Manufacturer Narrative

(b)(4).(b)(6).A review of all batch record documents was performed with no issues noted during the manufacturing process.There were no deviations from standard procedure and no exceptions related to the reported condition were noted.The sample was returned for evaluation.A visual inspection and leak testing were performed.During the leak test it was identified that there was a leak in the assembly between the tube and three-way clamp.The cause of the leak was a solvent dispenser failure during assembly.A capa has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ACCESS
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE - CALI; apartado aereo 2446 calle #36,; cali ; CO
• Manufacturer (Section G): BAXTER HEALTHCARE - CALI; apartado aereo 2446 calle #36,; cali ; CO
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3764307
• MDR Text Key: 20785346
• Report Number: 1416980-2014-12960
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: ARC2220P
• Device Lot Number: SX13JB8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2014
• Date Manufacturer Received: 03/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2013
• 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