MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION VASCU-GUARD; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Catalog Number	VG0108N
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	11/10/2022
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 particulate matter (pm) was found on a vascu-guard peripheral vascular patch.The pm was further described as, ¿fluff on the product¿.The pm was discovered during setup prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Actual and two (2) photographs of the sample were received for evaluation.Visual inspection was performed to the photograph and no particulate matter was observed.The reported condition is not clearly observed via the provided photograph.Meanwhile, the actual sample showed the jar and tamper evident label was torn which indicates that jar was opened.Additionally, the solution level was low which indicates that the patch was removed and some solution was poured out.The patch was removed from the jar and inspected which showed rough side of the tissue had black spot which is not present in the photo provided.It was also observed a significant number of hairs and particulate matter on the rough side of the tissue which indicates that the tissue was dropped.Therefore, the reported condition was verified.The cause of the condition was due to user related.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: VASCU-GUARD
• Common Device Name: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• 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: 16095056
• Report Number: 1416980-2022-07217
• Device Sequence Number: 15082138
• Product Code: DXZ
• UDI-Device Identifier: 00085412530895
• UDI-Public: (01)00085412530895
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K983602
• 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): 02/02/2023

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: VG0108N
• Device Lot Number: SP22A20-1615968
• 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: 12/09/2022
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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