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

Catalog Number 5990015

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

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

Event Date 03/29/2021

Event Type  malfunction  

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 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
• 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: 11708743
• MDR Text Key: 255838650
• Report Number: 1213643-2021-20089
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741130991
• UDI-Public: (01)00801741130991
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2020
• 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