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

Catalog Number 2C8537

Device Problems Disconnection (1171); Failure to Disconnect (2541)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturing facility-this device was manufactured at one of the two following manufacturing sites: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the connection of between a non-baxter connector and a clearlink system continu-flo solution set was broken.The event was initially described as the ¿clave connector broke on extension set when attached to iv tubing¿.Upon further investigation, it was reported the two devices ¿are not able to separate¿.This issue was identified during unspecified process step.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information was added to d10, h3 and h6.H10: the device was received for evaluation. visual inspection was performed and revealed that the clave connector was cracked into the male luer rigid component.The reported condition was verified. the cause of the crack was related to handling (force) of the device by the end user.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
• MDR Report Key: 9950100
• MDR Text Key: 187272629
• Report Number: 1416980-2020-02123
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K961225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C8537
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Date Manufacturer Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ICU MEDICAL EXTENSION SET; ICU MEDICAL EXTENSION SET