MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION FLO-THRU; CLAMP, VASCULAR

Catalog Number	FT12225
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2023
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 ftis 2.25/12mm had lint in the inner pouch.This issue was identified during inspection.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H10: the actual device was received for evaluation.Unaided eye inspection was performed through the double pouch configuration which identified a fiber-like object below the flo-thru shaft and located above the identification sticker on the clear side of the pouch.The object was free moving inside the pouch and determined to be a piece of trimmed hair.The reported condition was verified; however, the particulate size met manufacturing specifications.The cause of the condition could not be determined; however, the event was most likely due to inadvertent introduction of the particulate during the sealing process.The device was sterile as each pouched device underwent sterilization.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: FLO-THRU
• Common Device Name: CLAMP, VASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave. w; saint paul MN 55114
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16798416
• Report Number: 1416980-2023-01952
• Device Sequence Number: 15057017
• Product Code: DXC
• UDI-Device Identifier: 00085412532486
• UDI-Public: (01)00085412532486
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K981624
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2023

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: FT12225
• Device Lot Number: SP23C011826840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown