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	11/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As alleged, an air leakage was noted in the inner package of the ventralight st mesh package when it was opened for a case.The subject device was discarded as it was contaminated with the patient¿s blood.Based on the information provided and without having the sample to evaluate, no conclusion can be made.Review of manufacturing records shows product was made to specification.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 hernia surgery procedure, when the inner packaging was opened to take the ventralight st mesh, it was found that there was an air leakage in the inner packaging.It was reported that the surgeon worried about the risk of contamination and did not use the product.When the surgeon took out the mesh, the gloves were contaminated with the patient's blood and then disposed of as contaminated garbage.It was reported that there was no damage in outer package.
Additional Manufacturer Narrative
As alleged, an air leakage was noted in the inner package of the ventralight st mesh package when it was opened for a case.The subject device was discarded as it was contaminated with the patient¿s blood.Based on the information provided and without having the sample to evaluate, no conclusion can be made.Review of manufacturing records shows product was made to specification.Addendum: h11: this supplemental mdr is submitted to correct the initial reporter details.Updated fields: b4, g3, g6, h2, h6, h10, h11.Corrected fileds: e1, e3.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 hernia surgery procedure, when the inner packaging was opened to take the ventralight st mesh, it was found that there was an air leakage in the inner packaging.It was reported that the surgeon worried about the risk of contamination and did not use the product.When the surgeon took out the mesh, the gloves were contaminated with the patient's blood and then disposed of as contaminated garbage.It was reported that there was no damage in outer package.

• 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: 20924897
• Report Number: 1213643-2024-00580
• Device Sequence Number: 20157102
• Product Code: FTL
• UDI-Device Identifier: 00801741031625
• UDI-Public: (01)00801741031625(11)230709(17)250828(10)HUHW0343
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2025

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 Expiration Date: 08/28/2025
• Device Catalogue Number: 5954460
• Device Lot Number: HUHW0343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/07/2023
• 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