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

Catalog Number	2H8864
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/28/2020
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 a clearlink system non-dehp buretrol solution set was cracked and as a result leaked.This was described as the device ¿was primed with a saline to administer chemo and buretrol leaked¿.This was identified prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to d10, h3, h4 and h6.H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional test including pressure test and clear passage test was performed which revealed a leakage from the bottom of the burette chamber.The reported condition was verified.The cause of the condition was due to a manufacturing 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: 10737755
• Report Number: 1416980-2020-06662
• Device Sequence Number: 19864436
• Product Code: FPA
• UDI-Device Identifier: 00085412071749
• UDI-Public: (01)00085412071749
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K123874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2020

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: Other
• Device Catalogue Number: 2H8864
• Device Lot Number: DR20E15078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 10/26/2020
• Supplement Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1