MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK BURETROL SOLUTION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2C8862
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the tubing of a clearlink system buretrol solution set disconnected below the drip chamber.This was identified out of the package, before spiking intravenous (iv) fluids.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
The device was received for evaluation.A visual inspection was done which observed that the fill line (tubing) came apart (separated) from the bottom of the burette component.It was further noticed that there was a lack of solvent applied in this joint.Due to the nature of the defect, no functional testing could be performed.The reported condition was verified.The cause of the condition was due to a manufacturing related 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 BURETROL SOLUTION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11496855
• Report Number: 1416980-2021-01375
• Device Sequence Number: 3997130
• Product Code: FPA
• UDI-Device Identifier: 00085412073354
• UDI-Public: (01)00085412073354
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K123874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2021

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: Other
• Device Catalogue Number: 2C8862
• Device Lot Number: DR20I09073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1