MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INTRAVASCULAR EXTENSION SETS AND ACCESSORIES; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2N3368
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
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 two (2) air-eliminating 1.2 m solution filters cracked which resulted in fluid leaks.This issue was observed during an unspecified process step.There was no patient injury or medical intervention associated with this event.No additional information was available.
Additional Manufacturer Narrative
The actual device was not available; however, forty-three (43) companion samples were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Tip protector removal testing was performed, and no issues were noted.Burst leak testing, vent leak testing, and flow rate testing were also performed, and no issues were noted.The reported condition was not verified.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.
Additional Manufacturer Narrative
Correction: b4/f8: date of this report in follow-up mdr #1 is being corrected from blank to 07/12/2021.

• Brand Name: INTRAVASCULAR EXTENSION SETS AND ACCESSORIES
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11952041
• Report Number: 1416980-2021-03424
• Device Sequence Number: 16432524
• Product Code: FPA
• UDI-Device Identifier: 00085412639444
• UDI-Public: (01)00085412639444
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K192366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2021

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: 2N3368
• Device Lot Number: DR20I11079
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 07/12/2021; 07/12/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 07/12/2021; 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LIPIDS