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

Catalog Number 0112660

Device Problem Off-Label Use (1494)

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

Event Date 07/19/2022

Event Type  malfunction  

Event Description

As reported, the bard flat mesh was autoclaved prior to preparing a patient for hernia repair on (b)(6) 2022.As reported after autoclaving, the mesh size was reduced to the point where it could not be used.The procedure was completed using a non- bard/davol mesh.There was no reported patient injury.

Manufacturer Narrative

As reported, in was noted that ¿the bard flat mesh size was reduced to the point where it could not be used after the mesh was autoclaved at the user facility.Per the warning section of the instructions-for-use supplied with the device, ¿this mesh has been designed for single use only.Reuse, reprocessing, resterilization or repackaging may compromise the structural integrity and/or essential material and design characteristics that are critical to the overall performance of the device and may lead to device failure which may result in injury to the patient" and ¿reuse, reprocessing, resterilization or repackaging may also create a risk of contamination of the device and/or cause patient infection or cross infection, including, but not limited to, the transmission of infectious diseases from one patient to another.Contamination of the device may lead to injury, illness, or death of the patient or end user".Based on the as reported information and the investigation performed, the reported device ¿shrinkage¿ that occurred is a use related event with no manufacturing or device malfunction identified.Not returned.

• 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: 15477768
• MDR Text Key: 300997890
• Report Number: 1213643-2022-00628
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016516
• UDI-Public: (01)00801741016516
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0112660
• Device Lot Number: HUDY1899
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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