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

Catalog Number 5954450

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The sample was not returned for evaluation, however the user facility provided photos of the device packaging.The photos show an opened ventralight st inner foil pouch.There are creases and indentations that can be identified on the pouch as would be typical of a pouch that had been opened.The user facility did not report a concern for the packaging as presented prior to opening the pouch.The photos do not allow us to determine if a sterile barrier breach presented.Creases and indentations on the foil pouch are conditions that can present during the opening of the pouch with no compromise of the sterile barrier.The sample was discarded by the user facility, as such no conclusion can be made.

Event Description

It was reported that the hospital has concerns with how the foil pouch packaging of the ventralight st mesh looks after it is open and the mesh is removed.The concern is for compromised sterility.The contact stated it is hospital practice to hold the sterile pouch up to the light and visually examine before use.The implant was not used in the case.

• Brand Name: VENTRALIGHT ST MESH
• 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: 8189509
• MDR Text Key: 131341591
• Report Number: 1213643-2018-04896
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031618
• UDI-Public: (01)00801741031618
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101851
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 5954450
• Device Lot Number: HUBP0631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2017
• 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