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

Catalog Number VG0108N

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2021

Event Type  malfunction  

Event Description

It was reported that a hair was found in a vascu-guard product.This was identified before patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information: b5, e1: initial reporter last name, e1: initial reporter e-mail, d9, h3, h6, h10.B5: it was further reported the hair was found in the jar.H10: the sample was received for evaluation with the tamper-evident label broken.The tissue and a small amount of liquid were present inside the jar.Visual inspection of the sample was performed which identified two particulates ¿ a hair that appeared to be an eyelash and a smaller black fiber present on the tissue.No particulate matter was visible in the liquid remaining in the jar.The reported condition was verified.The cause of the condition 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
• Type of Device: 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 ; 2242702068
• MDR Report Key: 12910163
• MDR Text Key: 281534045
• Report Number: 1416980-2021-07064
• Device Sequence Number: 1
• Product Code: DXZ
• UDI-Device Identifier: 00085412530895
• UDI-Public: (01)00085412530895
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: VG0108N
• Device Lot Number: SP21H30-1567212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NA.