MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRIO ST; SURGICAL MESH

Catalog Number 5950050

Device Problems Use of Device Problem (1670); Expiration Date Error (2528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2018

Event Type  malfunction  

Manufacturer Narrative

This event is confirmed as a use related error.Our records show the device was provided to the facility on (b)(6) 2016, almost two years prior to the expiration date.The expiration date is located on multiple layers of the packaging.Remains implanted.

Event Description

As reported on (b)(6) 2018 a bard ventrio st mesh was implanted in the patient beyond its labeled expiration date.The or staff noted this after the mesh was in the patient.No additional medical or surgical treatment was performed.

• Brand Name: VENTRIO ST
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: laura sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 8216943
• MDR Text Key: 132495104
• Report Number: 1213643-2019-00033
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031540
• UDI-Public: (01)00801741031540
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101920
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/04/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2018
• Device Catalogue Number: 5950050
• Device Lot Number: HUAU1566
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 01/04/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/13/2016
• 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