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

Catalog Number	5955600
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, a 1mm piece of the retrieval loop broke off of the echo ps when pulling it up through the abdominal wall.As reported the surgeon was unable to locate the piece.Reporter states, it¿s possible the carter thompson device may have clipped the retrieval loop.Per sample evaluation, the retrieval loop is and was likely cut as reported.Visible on the retrieval loop are multiple cut marks in the material consistent with the use of the surgical tool.Based on the sample condition and reported event the retrieval loop was inadvertently damaged in use while retrieving the tube through the defect with the carter thompson device.Review of manufacturing records shows product was made 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 reported, during a laparoscopic ventral hernia repair with a ventralight st w/echo ps using 12 mm trocar and a carter thompson device.A small (1mm) piece of the retrieval loop broke off and fell into the patient's abdomen when pulling it up through the abdominal wall.As reported, it¿s possible the carter thompson device may have clipped the retrieval loop.The surgeon was not able to locate or retrieve the piece, and it was left in vivo.The case was completed and no reported patient injury.

• Brand Name: VENTRALIGHT ST W/ ECHO
• 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: 21527578
• Report Number: 1213643-2025-00078
• Device Sequence Number: 8396081
• Product Code: FTL
• UDI-Device Identifier: 00801741031731
• UDI-Public: (01)00801741031731(11)240708(17)260628(10)HUJU0271
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K130968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/13/2025

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: 06/28/2026
• Device Catalogue Number: 5955600
• Device Lot Number: HUJU0271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2024
• 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