MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 PHASIX ST W/ ECHO 2; ABSORBABLE MESH

Catalog Number	1210015
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the user experienced difficulty when inserting the device into the trocar with a grasper and the mesh had a gelatinous feel.Sample evaluation finds the mesh does not feel unusual and notes there is a small area where the st coating has separated from the mesh.No manufacturing anomalies were found.The separation of the st coating noted during sample evaluation most likely occurred while in use, as it was reported the user had difficulty deploying the mesh through the trocar using a grasper.Note it is intended that an introducer tool (provided with the device) be used to insert the device through the trocar.A review of manufacturing records was performed and found the device was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in march 2024.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 laparoscopic ventral hernia repair the phasix st mesh w/echo 2 was quickly dipped in saline prior to rolling it with the coated side of the mesh on the inside (per the ifu).A grasper was used to insert the device into the 12mm trocar.The implant unraveled (unrolled) in the trocar.The mesh was removed, and it was noted that it ¿felt different, gelatinous.¿ another phasix st w/echo 2 was used without any issues to complete the case.There was no patient harm or injury.

• Brand Name: PHASIX ST W/ ECHO 2
• Common Device Name: ABSORBABLE 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: 19980999
• Report Number: 1213643-2024-00404
• Device Sequence Number: 8375495
• Product Code: OWT
• UDI-Device Identifier: 00801741161223
• UDI-Public: (01)00801741161223(17)251228(10)HUJN0766
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K182008
• 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): 08/06/2024

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: 12/28/2025
• Device Catalogue Number: 1210015
• Device Lot Number: HUJN0766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2024
• 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