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

Catalog Number	0112680
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, small staple holes were identified on the bard flat mesh packages.The complainant indicated that "it appears the staples penetrated the outer box and punctured all mesh packages." review of photos provided was inconclusive.Inspection of returned sample finds four (4) holes in the product outer carton consistent with an object, likely a stapled item, having been attached to the carton at some point after distribution.The three (3) inner tyvek pouches contained within the carton each had holes that aligned with the holes in the outer carton.The punctures were present on both sides of each pouch, consistent with penetration by a staple or similar sharp fastener.Based on the returned condition, the damage occurred due to post-distribution handling and is not indicative of a manufacturing issue.Examination of the pouches confirmed that all seals were intact and properly formed, with no evidence of seal defects or manufacturing anomalies.A review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 1,080 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, the or nurse observed small holes in the packaging of a bard flat mesh.Two (2) additional packages from the same box (packaged three (3) per case) were inspected and found to have holes in the same location.On the outside of the box there were four (4) holes, suggesting that something had been stapled to the box in two (2) separate areas.It appears the staples penetrated the outer box and punctured all mesh packages.

• Brand Name: BARD FLAT 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: 24618188
• Report Number: 1213643-2026-00341
• Device Sequence Number: 10138092
• Product Code: FTL
• UDI-Device Identifier: 00801741016530
• UDI-Public: (01)00801741016530(17)300128(10)HUKP0322
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2026

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: 0112680
• Device Lot Number: HUKP0322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2025
• 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