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

Catalog Number 5954680

Device Problem Device Expiration Issue (1216)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/07/2016

Event Type  malfunction  

Manufacturer Narrative

This initial mdr is being submitted as a result of a retrospective review of davol's mdr decisions and the initial decision not to report the event is being revised to reflect updated company procedures.Based upon review of the lot number for the product (hux10492), the product would have had a labeled expiry date of september 2015.As reported, both the bard sales representative and user facility failed to check the expiration date on the device prior to delivery and implant procedure, resulting in a device beyond it expiration date being implanted.The device remains implanted, no patient harm has been reported.Action has been taken locally to prevent recurrence.Remains implanted.

Event Description

It was reported that the sales rep visited the hospital to trial a product with a physician and left a unit for the hospital to use.It was then reported by the facility that the device had been used successfully in a procedure.The facility reported that after the device had been implanted it was noted the expiry date was september 2015.The device remains implanted, no patient harm has been reported.

• 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 6743440
• MDR Text Key: 81008096
• Report Number: 1213643-2017-00423
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031656
• UDI-Public: (01)00801741031656(17)150928(10)HUXI0492
• Combination Product (y/n): N
• PMA/PMN Number: K101851
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/26/2017

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: 09/28/2015
• Device Catalogue Number: 5954680
• Device Lot Number: HUXI0492
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2016
• Initial Date FDA Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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