MAUDE Adverse Event Report: BAXTER HEALTHCARE CLEARLINK STOPCOCK AND I.V. SOLUTION ADMINISTRATION SETS; STOPCOCK, I.V. SET

Catalog Number 2C6255

Device Problems Kinked (1339); Failure to Prime (1492)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a clearlink stopcock and i.V.Solution administration set was kinked and prime was unable to be completed.The tubing was kinked out of package and would not straighten out once hanged.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.During visual inspection, it was revealed that the tubing was kinked.The reported condition was verified.The cause of the condition was not determined.An ncr has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK STOPCOCK AND I.V. SOLUTION ADMINISTRATION SETS
• Type of Device: STOPCOCK, I.V. SET
• 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: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5552063
• MDR Text Key: 42034187
• Report Number: 1416980-2016-06695
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130245
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2020
• Device Catalogue Number: 2C6255
• Device Lot Number: R15F15115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2015
• 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