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

Catalog Number 5955800

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2019

Event Type  malfunction  

Manufacturer Narrative

This event is confirmed as a use related error.The user facility reported that on (b)(6) 2019 they implanted a ventralight st mesh (w/ echo ps) that had an expiry date of 09/28/2018.Our records show the product was provided to the facility on 11/28/2016, almost two years prior to the expiration date.The expiration date is contained on each level of packaging.Device evaluated by mfr? remains implanted.

Event Description

It was reported that on (b)(6) 2019, the surgeon implanted an expired ventralight st mesh (w/ echo ps) into the patient.The labeled expiration date is 9/28/2018.As reported device was received from the hospital inventory and there was no additional medical or surgical intervention and no patient injury as a result of the reported event.

• 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: 8343818
• MDR Text Key: 136618284
• Report Number: 1213643-2019-00879
• 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: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2018
• Device Catalogue Number: 5955800
• Device Lot Number: HUAX0102
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2016
• 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