MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK CONTINU-FLO STOPCOCK AND I.V. SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2C6255
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that when removing the blue cap of a clearlink system continu-flo solution set, the tubing completely separated from the hard plastic.This was identified during preparation.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information was added: the device was received for evaluation.A visual inspection was performed, and it was noted that the tubing was separated from the male luer.Further inspection was performed, and it was noted that there was no lack of solvent applied around the circumference of the tubing during assembly.The insertion of the tubing into the male luer was determined to be according to specification.Dimensional testing was also performed, and it was noted that the tubing dimensions were measured to be according to specification.The reported condition was verified.The most probable cause of the reported condition was a user error while the customer was removing the blue cover from the male luer.A nonconformance 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.

• Brand Name: CLEARLINK CONTINU-FLO STOPCOCK AND I.V. SOLUTION ADMINISTRATION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9796002
• Report Number: 1416980-2020-01235
• Device Sequence Number: 2770392
• Product Code: FPA
• UDI-Device Identifier: 00085412046310
• UDI-Public: (01)00085412046310
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K130245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2020

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
• Operator of Device: Health Professional
• Device Catalogue Number: 2C6255
• Device Lot Number: R19F05047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 04/08/2020
• Patient Sequence Number: 1