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

Catalog Number ARC2220P

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 12/10/2014

Event Type  malfunction  

Event Description

During evaluation of a returned access set, it was identified that the set leaked from the connection of the tubing and the y site.No additional information is available.

Manufacturer Narrative

(b)(4).The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.An underwater leak test was performed, and revealed a leak at the connection of the tubing to the y site.The cause of the condition was determined to be a lack of solvent application.To correct the condition, the production process was updated.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 4394967
• MDR Text Key: 5308229
• Report Number: 1416980-2015-00839
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/10/2014

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: Other
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: ARC2220P
• Device Lot Number: SE14GM6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2014
• Initial Date FDA Received: 01/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2014
• 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