MAUDE Adverse Event Report: BAYLIS MEDICAL CO., INC. VERSACROSS TRANSSEPTAL SHEATH; INTRODUCER, CATHETER

Model Number VXS85-35-63-45-D1

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem Insufficient Information (4580)

Event Date 04/28/2021

Event Type  malfunction  

Event Description

A live bug was found inside the package upon opening the sterile package.

• Brand Name: VERSACROSS TRANSSEPTAL SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BAYLIS MEDICAL CO., INC.; 1320 route 9; champlain NY 12919
• MDR Report Key: 11824675
• MDR Text Key: 250635477
• Report Number: 11824675
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: VXS85-35-63-45-D1
• Device Lot Number: VXFG220121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/07/2021
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27010 DA