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

Catalog Number 5955800

Device Problems Shelf Life Exceeded (1567); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2018

Event Type  malfunction  

Manufacturer Narrative

As reported the expired device was inadvertently implanted.Our review shows that the lot was provided to the customer prior to the expiration date.The product is packaged with the expiration clearly displayed on each level of packaging.The instructions-for-use instructs the user to inspect the package prior to use.This event is confirmed to be solely a use related error.Note: the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Implanted.

Event Description

It was reported that on (b)(6) 2018 during a laparoscopic repair of an incarcerated ventral hernia a davol ventralight st w/ echo was implanted that had been retrieved from the hospital inventory.As reported, after the procedure was completed, during a routine documentation of the devices used in the procedure it was noted the expiration date of the mesh was (b)(6) 2018.As reported the surgeon decided to leave the mesh implanted with no further medical or surgical intervention.

• Brand Name: VENTRALIGHT ST W/ ECHO
• 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: 7412924
• MDR Text Key: 105384380
• Report Number: 1213643-2018-00986
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031779
• UDI-Public: (01)00801741031779
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130968
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2018
• Device Catalogue Number: 5955800
• Device Lot Number: HUAN0488
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2016
• 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