MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO 2; SURGICAL MESH

Catalog Number	5990015
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, upon implant a ¿piece of plastic¿ , was noted to be sticking to the surface of the ventralight st mesh.The plastic piece was removed from the mesh and provided for evaluation.Visual examination of the received ¿plastic piece¿ confirmed it is not a component of the device or of the device¿s packing.In addition, the received piece of plastic did not contain any markings that would help to identify its possible source.Based on the sample evaluation and the investigation performed, the source of the plastic material could not be determined.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of 90 units released for distribution in december, 2020 if further information is obtained that indicates a possible source of the ¿plastic piece¿ a semdr will be submitted to document these findings.Sample evaluated.
Event or Problem Description
As reported, on (b)(6) 2021 during an umbilical hernia repair procedure, a bard/davol ventralight st w/echo 2 positioning system (ps) was used.After successfully fixating the mesh, the ps frame was removed and the surgeon noted a piece of plastic sticking to the mesh surface.As reported, the surgeon removed the piece and placed into a specimen cup.The mesh was successfully implanted.There was no reported patient injury.

• Brand Name: VENTRALIGHT ST W/ ECHO 2
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 11708743
• Report Number: 1213643-2021-20089
• Device Sequence Number: 4330975
• Product Code: FTL
• UDI-Device Identifier: 00801741130991
• UDI-Public: (01)00801741130991
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K170294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2021

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: 09/28/2021
• Device Catalogue Number: 5990015
• Device Lot Number: HUEX1721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other