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

Catalog Number	0115322
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the 3dmax mesh was noted to be torn upon removed from package.The subject device was returned for evaluation.As received, there are visible frays/tearing in the edge seal of the mesh and visible blood contamination.In one location of the edge seal, the tear has traveled slightly into the mesh fibers and the found edge seal tearing condition is not indicative of the manufactured condition.No manufacturing anomalies were found.Based on the sample evaluation and investigation performed, the root cause of the fraying/tearing of the edge seal condition found most likely inadvertently occurred during user/device interface while in preparation to deploy the mesh.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of 209 units released for distribution in (b)(6) 2018.This mdr is submitted to represent the bard/davol 3dmax (device #1).An additional mdr is submitted to represent the bard/davol 3dmax (device #2).Sample evaluated.
Event or Problem Description
As reported, during an unknown procedure on (b)(6) 2022, the bard/davol 3dmax mesh (device #1) tore upon removal from the package.As reported, the mesh was not used and another bard/davol 3dmax mesh (device #2) was opened, which tore as well.The procedure was completed using an unknown mesh.There was no reported patient injury.

• Brand Name: 3DMAX
• Common Device Name: 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: 14580379
• Report Number: 1213643-2022-00370
• Device Sequence Number: 20184498
• Product Code: FTL
• UDI-Device Identifier: 00801741030772
• UDI-Public: (01)00801741030772
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2023
• Device Catalogue Number: 0115322
• Device Lot Number: HUCS1740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown