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

Catalog Number	5955800
Medical Device Problem Codes	Shelf Life Exceeded (1567); Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/21/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 7412924
• Report Number: 1213643-2018-00986
• Device Sequence Number: 19194095
• Product Code: FTL
• UDI-Device Identifier: 00801741031779
• UDI-Public: (01)00801741031779
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K130968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/10/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2018
• Device Catalogue Number: 5955800
• Device Lot Number: HUAN0488
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1