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

Catalog Number	5954450
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As alleged a corner of the inner paper envelope containing the ventralight st mesh was sealed within the foil pouch seal.The physical sample has been received for evaluation and the initial review finds no evidence that the inner paper envelope was sealed within the foil pouch seal.Note, the seal in question is sealed prior to placement of the envelope into the foil pouch.Further review of the returned sample is currently ongoing, as such no conclusions have been made.When the sample evaluation is complete, a supplemental mdr will be submitted.Review of the manufacturing records was performed and found the lot was manufactured to specification.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 alleged, when the inner foil package of the ventralight st mesh was opened, the customer reports that the corner of the mesh envelope was sealed in the foil packaging.The operating room staff did not trust it to be sterile and was not used.The procedure was completed with another mesh.There was no patient injury.
Additional Manufacturer Narrative
As alleged a corner of the inner paper envelope containing the ventralight st mesh was sealed within the foil pouch seal.The physical sample has been received for evaluation and the initial review finds no evidence that the inner paper envelope was sealed within the foil pouch seal.Note, the seal in question is sealed prior to placement of the envelope into the foil pouch.Further review of the returned sample is currently ongoing, as such no conclusions have been made.When the sample evaluation is complete, a supplemental mdr will be submitted.Review of the manufacturing records was performed and found the lot was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.Addendum this supplemental mdr is submitted to document the sample evaluation results.Sample evaluation confirms the presence of visible foil-to-foil primary sealing and evidence of complete adhesive transfer.Evaluation shows the pouch was sealed correctly, and the inner paper (tyvek) envelope did not damage the seal.The tyvek envelope was not caught within the seal.The seal in question is sealed prior to the tyvek envelope being placed into the foil pouch.Examination of the seal confirms there was no breach to the package prior to opening.The tyvek envelope was identified free inside the pouch with no finding that could harm the chevron sealed side.The product meets product specifications.Updated fields: b4, g3, g6, h2, h3, h6, h10 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 alleged, when the inner foil package of the ventralight st mesh was opened, the customer reports that the corner of the mesh envelope was sealed in the foil packaging.The or staff did not trust it to be sterile and was not used.The procedure was completed with another mesh.There was no patient injury.

• Brand Name: VENTRALIGHT ST
• 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: 22071189
• Report Number: 1213643-2025-00407
• Device Sequence Number: 18482457
• Product Code: FTL
• UDI-Device Identifier: 00801741031618
• UDI-Public: (01)00801741031618(11)250107(17)261228(10)HUJZ1468
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 05/26/2025

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: 5954450
• Device Lot Number: HUJZ1468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2025
• 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