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

Catalog Number ARC2220P

Device Problem Failure to Prime (1492)

Patient Problem No Patient Involvement (2645)

Event Date 04/06/2015

Event Type  malfunction  

Event Description

It was reported that a customer was unable to prime an access set.The customer stated that the device presented a blockage which prevented it from priming.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).The device was received and the evaluation was completed to investigate the reported issue.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Underwater leak testing was performed with flow obstruction observed between the injection site and tube assembly.The cause of the condition was determined to be excess solvent.Therefore, the reported condition was verified through evaluation.A capa has been opened to address this issue.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.

Manufacturer Narrative

(b)(4).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: 4695346
• MDR Text Key: 5671913
• Report Number: 1416980-2015-16960
• 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,Followup
• Report Date: 04/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: ARC2220P
• Device Lot Number: SE14LD7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2014
• 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