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

Catalog Number	1201015
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	11/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported on (b)(6) 2025 during two separate cases for hiatal hernia repair, the user facility reports that the foil pouches once opened had pin holes along with deep scratches and are concerned they have been compromised.Breach of sterility.They alleged they can see light through the pouch when using a flashlight during inspection.The facility performed an inventory inspection opening multiple products (phasix st, ventralight st, phasix ops, phasix echo) with the same condition of damage.The two cases were completed using another device that did not exhibit the same issue.This resulted in an inconsequential delay.There was no patient harm as a result of the problem experienced.This mdr represents the 1 phasix st mesh from lot number huks2055 opened by the customer.
Additional Manufacturer Narrative
Samples returned were inspected to evaluate the integrity of the foil pouches.This included visual inspection under magnification, and dye penetrations testing (per astm f3039).As reported and found the opened foil pouches had areas of indentations, striations, deformation.All visual observations are anticipated conditions that may present when opening the foil pouches.There were no breaches of the material found during dye testing.Visual examination confirms the seal transfers were intact at the time of manufacturer.Review of the manufacturing records confirms the device was manufactured to specification.The instructions-for-use, supplied with the device states, "this mesh is supplied sterile.Prior to use, carefully examine package and product to verify neither is damaged and that all seals are intact.Do not use if the foil pouch or package is damaged or open, or if the center of the temperature indicator on the foil pouch is black." the foil pouch used on bd st products uses aluminum as the moisture and oxygen barrier material.The pet, ldpe, and the peelable film are sandwiching the aluminum.The pet, ldpe, and the peelable film comprise the sterile barrier.During normal handling and opening, the pouch material can result in visual marks.These marks are expected based upon use and are acceptable based upon validation testing.Sometimes during opening, the pouch material can be stretched while pulling and folding back parts of the pouch.This stretching can result in ¿cracks¿ or ¿pinholes¿ in the aluminum layer.The pet, ldpe, and peelable film layers are still intact.Even if light can be seen through the foil layer as the pet, ldpe, and peelable film layers are transparent.Aluminum is a metal and in thin layers is very impressionable to forces placed on it.The plastic layers surrounding the aluminum bolster it and keep everything together.A level of visual marks are normal and acceptable as long as the total structure remains intact.This mdr represents the phasix st mesh lot number huks2055.Additional mdrs were submitted to represent the additional product codes / lot numbers of the evaluated products.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.

• Brand Name: PHASIX 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: 23630793
• Report Number: 1213643-2025-01129
• Device Sequence Number: 9317837
• Product Code: OWT
• UDI-Device Identifier: 00801741095344
• UDI-Public: (01)00801741095344(11)250529(17)280428(10)HUKS2055
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• 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
• Report Date (Section B): 11/11/2025

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: 1201015
• Device Lot Number: HUKS2055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2025
• 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