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

Catalog Number 0112680

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/25/2020

Event Type  malfunction  

Manufacturer Narrative

As reported, the sealed packaging of a bard flat mesh was opened and the surgeon identified a hair within the ¿little holes¿ of the mesh.The sample was not returned for evaluation, however a photo of the bard mesh in question was provided.The photo depicts the mesh removed from the package, contaminated with blood and a hair in/on the mesh.As the photo provided depicts the mesh out of the package and contaminated, the photo does not assist in determining whether the hair was introduced after opening the package or if the hair was present prior to opening the package.Based on the photo evaluation, this complaint is confirmed with an undetermined root cause.A review of the manufacturing records was performed and found that the lot was manufactured to specification.

Event Description

It was reported that for a herniorrhaphy procedure, the sealed packaging of a bard flat mesh was opened and the surgeon identified a hair within the ¿little holes¿ of the mesh.The mesh had no contact with the patient and the procedure was completed with another identical bard flat mesh.

• Brand Name: BARD FLAT MESH
• 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: 10161792
• MDR Text Key: 195730651
• Report Number: 1213643-2020-05890
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016530
• UDI-Public: (01)00801741016530
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2023
• Device Catalogue Number: 0112680
• Device Lot Number: HUCY1075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2018
• 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