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

Catalog Number 5950008

Device Problem Expiration Date Error (2528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2020

Event Type  malfunction  

Manufacturer Narrative

The user facility reported that they inadvertently implanted an expired ventralex st mesh into the patient.The expiration date is located on multiple layers of the packaging.This event is confirmed as a use related error with no malfunction of the device.As reported the surgeon has no clinical concerns for the patient at this time.Review of manufacturing records indicate product was manufactured and labeled to specification.Should additional information be provided, a supplemental emdr will be submitted.Not returned - remains implanted.

Event Description

It was reported that on (b)(6) 2020, the patient was implanted with a bard/davol ventralex st with an expiration date of 28-mar-2020.It was reported that the packaging was intact and product appeared to function as intended.The patient was notified and is being followed up for 90 days per hospital policy.There was no reported patient injury and additional medical or surgical intervention was not necessary.

• Brand Name: VENTRALEX ST
• 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: 10401629
• MDR Text Key: 202718128
• Report Number: 1213643-2020-07355
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031489
• UDI-Public: (01)00801741031489
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2020
• Device Catalogue Number: 5950008
• Device Lot Number: HUCP1988
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2018
• 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