MAUDE Adverse Event Report: VENTRIO MESH; SURGICAL MESH

Catalog Number	0010216
Medical Device Problem Codes	Contamination of Device Ingredient or Reagent (2901); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, no conclusion can be made.Returned for evaluation were four (4) small round white pieces of the alleged foreign material found by the user within the product packaging.Preliminary evaluation finds the returned material is round and plastic in nature.Review of the returned sample is ongoing at this time.When the sample evaluation is completed, a supplemental mdr will be submitted.A review of manufacturing records shows product was manufactured to specification.To date, this is the only complaint reported for this manufacturing lot of (b)(4) units released for distribution in june, 2019.
Event or Problem Description
As reported, upon opening the package of the bard/davol ventrio mesh during a procedure on (b)(6) 2021, a "white foreign material" was noted within the inner package.As reported, no damage was noted on the outer package and the mesh was implanted in the patient.There was no reported patient injury.
Additional Manufacturer Narrative
At this time, no conclusion can be made.Returned for evaluation were four (4) small round white pieces of the alleged foreign material found by the user within the product packaging.Preliminary evaluation finds the returned material is round and plastic in nature.Review of the returned sample is ongoing at this time.When the sample evaluation is completed, a supplemental mdr will be submitted.A review of manufacturing records shows product was manufactured to specification.To date, this is the only complaint reported for this manufacturing lot of (b)(4) units released for distribution in june, 2019.Addendum: this is an addendum to the initial mdr, to document our investigation results.Based on visual and manufacturing process evaluation performed, the origin of the white foreign material could not be matched with a manufacturing generated condition.Based on manufacturing record review, no raw material component or sub assembly generated at the manufacturing site was identified with a similarity that could be related to condition reported.Based on the sample evaluation and the investigation performed, the source of the plastic material could not be determined.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : sample evaluated.
Event or Problem Description
As reported, upon opening the package of the bard/davol ventrio mesh during a procedure on (b)(6) 2021, a "white foreign material" was noted within the inner package.As reported, no damage was noted on the outer package and the mesh was implanted in the patient.There was no reported patient injury.

• Brand Name: VENTRIO MESH
• Common Device Name: SURGICAL MESH
• MDR Report Key: 12638717
• Report Number: 1213643-2021-20363
• Device Sequence Number: 19656363
• Product Code: FTL
• UDI-Device Identifier: 00801741016431
• UDI-Public: (01)00801741016431
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2021

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: 10/28/2022
• Device Catalogue Number: 0010216
• Device Lot Number: HUDP1027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Initial Date Received by Manufacturer: 09/24/2021
• Supplement Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 11/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2019
• 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