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 Patient Involvement (2645)
Date of Event	07/02/2020
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 white particulate matter was found floating inside the packaging of a vascu-guard patch.This was identified during setup and preparation prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to d10, h3, and h6.H10: the actual sample was received for evaluation.A visual inspection was performed, and no foreign particulate matter was visible floating in the solution; however, a loose tissue fiber was observed on the surface of the tissue.It was unknown if the fiber was what the customer observed to be particulate matter.No other particulate matter was visible on the returned sample.The cause of the loose tissue fiber could not be determined.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
• MDR Report Key: 10344231
• Report Number: 1416980-2020-04551
• Device Sequence Number: 3217878
• Product Code: DXZ
• UDI-Device Identifier: 00085412530895
• UDI-Public: (01)00085412530895
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K983602
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2020

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: 02/05/2025
• Device Catalogue Number: VG0108N
• Device Lot Number: SP20E13-1450823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 09/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1