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

Catalog Number	2C8858
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that three (3) paclitaxel sets leaked.The events occurred in the pharmacy during preparation.The leaks were observed from the tubing under the drip chamber.No patient involvement.No additional information is available.
Additional Manufacturer Narrative
Device manufacturer address 1: (b)(4) parque industrial.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H10: one actual device was received for evaluation.The other two (2) samples were not received and therefore, could not be evaluated.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A functional testing was performed including clear passage and pressure testing which revealed a leak between the assembly of the tubing into the drip chamber.Additional priming was performed at the set with a bag of sterile water which revealed a leak in the same area.The assembly of the tubing into the drip chamber was not according to specifications; low assembly was detected.The reported condition was verified.The cause of the condition was due to assembly issue during the manufacturing process.A batch review was conducted on both of the suspect lot numbers and there were no deviations found related to this reported condition during the manufacture of these lots.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK SOLUTION ADMINISTRATION SETS
• 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 60073 ; 2242702068
• MDR Report Key: 15749671
• Report Number: 1416980-2022-06056
• Device Sequence Number: 6364563
• Product Code: FPA
• UDI-Device Identifier: 00085412071688
• UDI-Public: (01)00085412071688
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K160007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2022

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 Catalogue Number: 2C8858
• Device Lot Number: R22E05147
• 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: 10/11/2022
• Supplement Date Received by Manufacturer: 11/24/2022
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2022
• 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