MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX; SURGICAL MESH

Catalog Number 0115322

Device Problem Expiration Date Error (2528)

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

Event Date 01/27/2022

Event Type  malfunction  

Event Description

The customer was provided with an expired 3dmax mesh on (b)(6) 2022.The mesh expiration date is 28-dec-2021.General surgeon used it in a patient in a procedure on (b)(6) 2022.When provided by the courier the user facility did not notice the expired date as being past.On the day of surgery the or team did not identify the product expiration before use.Surgeon planned to discuss the event with the patient, and there was no reported action taken.No patient injury reported.

Manufacturer Narrative

As reported, an expired 3dmax was inadvertently implanted into the patient.The expiration date is located on each layer packaging.This event is confirmed as a use related error as the or staff should have identified the condition prior to use.The local courier had taken the implant from a consignment location at another facility and delivered it to the hospital.The courier did not check the expiration date before transferring the inventory.

• Brand Name: 3DMAX
• 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: 13590205
• MDR Text Key: 289330870
• Report Number: 1213643-2022-00024
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741030772
• UDI-Public: (01)00801741030772
• Combination Product (y/n): N
• PMA/PMN Number: K081010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2021
• Device Catalogue Number: 0115322
• Device Lot Number: HUBN0084
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2017
• 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