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

Catalog Number 2C8541

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/23/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the retractable iv tubing tips of four (4) clearlink system continu-flo solution sets broke off in an extension tubing (non-baxter) when trying to disconnect the iv (intravenous) tubing from the iv extension tubing.This issue was identified during patient use and as a result the customer had to undress the site and change the extension tubing at the iv catheter site.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: only one (1) sample was received for evaluation.The other three (3) samples were not received and therefore, could not be evaluated.The sample that was received was a used segment together with one used sample of an extension tubing with a connector (non-baxter product).A visual inspection was performed to samples using the naked eye and it was observed that the male luer rigid component was cracked into the tubing connector of the extension set.Additionally, an appearance of white color was observed on the cracked components evidencing a trace of external force applied to the components.The reported condition was verified.The cause of the condition could not be determined, however, it was noted that the issue was possibly related to the force applied to disconnect the iv (intravenous) tubing from the extension tubing.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK DUO-VENT 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; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 12705090
• MDR Text Key: 278594737
• Report Number: 1416980-2021-06484
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K961225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C8541
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2021
• 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: Initial
• Patient Sequence Number: 1
• Treatment: IV EXTENSION TUBING -BRAUN; IV EXTENSION TUBING -BRAUN