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

Catalog Number	5954460
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the envelope containing the ventralight st mesh was stuck within the seal of the sterile foil pouch.The pouch was received opened from the chevron end as intended and the inner envelope which contains the mesh is found to be stuck in the manufacturing seal as reported.Further review of the returned sample is currently ongoing.When the sample evaluation is complete, a supplemental mdr will be submitted.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.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.
Event or Problem Description
As reported, during a ventral hernia repair procedure when the sterile foil pouch containing the envelope with the ventralight st mesh was opened, the envelope was noted to be stuck within the seal of the sterile foil pouch.The customer felt the mesh was unsterile and used another mesh to complete the procedure.There was no patient injury.
Additional Manufacturer Narrative
As reported, the envelope containing the ventralight st mesh was stuck within the seal of the sterile foil pouch.The pouch was received opened from the chevron end as intended and the inner envelope which contains the mesh is found to be stuck in the manufacturing seal as reported.Further review of the returned sample is currently ongoing.When the sample evaluation is complete, a supplemental mdr will be submitted.To date, this is the only reported complaint for this manufacturing lot of 420 units.Addendum: this supplemental mdr is submitted to document the sample evaluation results.Based on sample and manufacturing process evaluation performed, returned sample condition is determined to be a manufacturing-generated condition.Root cause is an incorrect foil-foil sealing process and visual inspection performed during the manufacturing of the product.Awareness training regarding the found condition was provided to the appropriate manufacturing personnel.A cid was issued for further investigation.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.
Event or Problem Description
As reported, during a ventral hernia repair procedure when the sterile foil pouch containing the envelope with the ventralight st mesh was opened, the envelope was noted to be stuck within the seal of the sterile foil pouch.The customer felt the mesh was unsterile and used another mesh to complete the procedure.There was no patient injury.

• Brand Name: VENTRALIGHT ST MESH
• 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: 22099733
• Report Number: 1213643-2025-00414
• Device Sequence Number: 7372745
• Product Code: FTL
• UDI-Device Identifier: 00801741031625
• UDI-Public: (01)00801741031625(11)241118(17)261028(10)HUJY1245
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• 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,Followup
• Report Date (Section B): 05/29/2025

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 Catalogue Number: 5954460
• Device Lot Number: HUJY1245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2024
• 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