MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK CONTINU-FLO SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2C8519

Device Problems Break (1069); Failure to Disconnect (2541)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Event occurred during the unspecified date of (b)(6) 2020.(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the luer of clearlink system continu-flo solution set would not disconnect.The event was further described as ¿when trying to disconnect the fluids, the connecting picc at the end of the fluid line was stuck inside the connecting part of the port line¿.The tubing then ¿broke at the end, leaving a small piece of plastic tubing from the fluid tubing in the end of the port tubing¿.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information was: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK CONTINU-FLO SOLUTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 9829327
• MDR Text Key: 183274031
• Report Number: 1416980-2020-01379
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C8519
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: PICC LINE; UNSPECIFIED FLUIDS
• Patient Age: 64 YR