MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALEX ST; SURGICAL MESH

Catalog Number 5950008

Device Problem Expiration Date Error (2528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/13/2022

Event Type  malfunction  

Manufacturer Narrative

As reported, an expired bard/davol ventralex mesh was inadvertently implanted into the patient.The expiration date is located on multiple layers of the packaging.This event is confirmed as a use related error as the or staff should have identified the condition prior to use.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of 403 units released for distribution in july, 2020.Returned - remains implanted.

Event Description

As reported, on (b)(6) 2022 during an unknown procedure, a bard/davol ventralex st, medium mesh which expired on (b)(6) 2022 was implanted into the patient.As reported, the packaging was completely intact prior to use.The product was retrieved from hospital inventory.There was no additional medical or surgical intervention reported.There was no reported patient injury.

• Brand Name: VENTRALEX ST
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 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 ; 8005566756
• MDR Report Key: 14853701
• MDR Text Key: 295405062
• Report Number: 1213643-2022-00480
• 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: Other,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2022
• Device Catalogue Number: 5950008
• Device Lot Number: HUEQ1495
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2020
• 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
• Patient Outcome(s): Other