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

Catalog Number	2R8402
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a clearlink system non-dehp solution set was dripping and leaking below the drip chamber.It was not specified when in the process step this occurred.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
(b)(6).(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H10: the device was received for evaluation.Visual inspection was performed using the naked eye which did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed including clear passage and pressure testing which revealed a leak between the assembly of the tubing into the drip chamber.The assembly of the tubing into the drip chamber was according to specification.Priming was performed on the set with sterile water which observed a leak at the affected area.Dimensional testing was performed at the tubing which met specifications.The reported condition was verified.The cause of the condition was due to an improper manual assembly during the manufacturing process.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK SYSTEM SOLUTION SET
• Common Device Name: 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: 14271602
• Report Number: 1416980-2022-02166
• Device Sequence Number: 5621190
• Product Code: FPA
• UDI-Device Identifier: 00085412676623
• UDI-Public: (01)00085412676623
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K180739
• 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,Followup
• Report Date (Section B): 08/08/2022

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 Expiration Date: 05/06/2023
• Device Catalogue Number: 2R8402
• Device Lot Number: R21E05136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2022
• Supplement Date Received by Manufacturer: 06/01/2022; 08/04/2022
• Initial Report FDA Received Date: 05/03/2022
• Supplement Report FDA Received Date: 06/03/2022; 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown