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

Catalog Number 0112680

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 02/03/2022

Event Type  malfunction  

Event Description

As reported, during an open inguinal hernia repair procedure, the bard flat mesh was placed in the patient.It is reported that while suturing the mesh tore.It was reported that the torn mesh was removed and another mesh with a different lot number was implanted.As reported this resulted in an additional 15-20 minutes of operating time.There was no reported patient injury.

Manufacturer Narrative

As reported, the bard flat mesh tore during fixation.The subject device was returned for evaluation.Visual evaluation found that the mesh had been tailored.The user, created a v-shape in the mesh.It appears that the mesh was cut inward from the edges and was then pulled into the v-shape with areas unraveling from forces applied.Also returned were what appear to be two supporting tails created from the mesh with suture placed in one tail.No manufacturing anomalies were noted.Based on the sample evaluation and investigation performed, the root cause for the torn mesh condition is consistent with the forces applied in use.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of 1,029 units released for distribution in (b)(6) 2021.Regarding tailoring of the mesh the instructions-for-use, supplied with the device state, intact bard mesh exhibits high burst and tensile strength.However, when custom tailoring, in special circumstances where excessive force is placed on the mesh, the following guidelines may be helpful: when cutting a notch in the mesh, a v-shape with a radiused point will withstand more force than a v-shape which comes to a sharp point.Sample evaluated.

• Brand Name: BARD FLAT MESH
• 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: 13590204
• MDR Text Key: 289271031
• Report Number: 1213643-2022-00023
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016530
• UDI-Public: (01)00801741016530
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• 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: 02/08/2022

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 Catalogue Number: 0112680
• Device Lot Number: HUFR1874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2022
• Date Manufacturer Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2021
• 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