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

Catalog Number	5955450
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial evaluation of the received sample finds that the two mesh connectors are present on the balloon with only one attached through to the mesh.There is a hole in the mesh in the location that the detached connector would have been attached.Review of the returned sample is currently ongoing, as such no conclusions have been made.When the sample evaluation is completed, a supplemental mdr will be submitted.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of 191 units released for distribution in nov, 2022.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.H3 other text : sample evaluated.
Event or Problem Description
As reported, during laparoscopic ventral hernia repair procedure it was noted that the ventralight st w/echo ps coil was pulled out when removed from the package prior to use.It was reported that no damage was noted to the product package.The procedure was completed using new mesh.There was no reported patient injury.
Additional Manufacturer Narrative
Initial evaluation of the received sample finds that the two mesh connectors are present on the balloon with only one attached through to the mesh.There is a hole in the mesh in the location that the detached connector would have been attached.Review of the returned sample is currently ongoing, as such no conclusions have been made.When the sample evaluation is completed, a supplemental mdr will be submitted.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of 191 units released for distribution in nov, 2022.Addendum: h11: this supplemental mdr is submitted to document the sample evaluation results.Based on the sample evaluation and investigation performed, root cause is determined to be manufacturing related possibly occurring during the assembly process.Awareness notification was provided to all appropriate personnel.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 laparoscopic ventral hernia repair procedure it was noted that the ventralight st w/echo ps coil was pulled out when removed from the package prior to use.It was reported that no damage was noted to the product package.The procedure was completed using new mesh.There was 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: 16818142
• Report Number: 1213643-2023-00160
• Device Sequence Number: 7124554
• Product Code: FTL
• UDI-Device Identifier: 00801741031717
• UDI-Public: (01)00801741031717
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K130968
• 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,Followup
• Report Date (Section B): 05/06/2023

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: 09/28/2024
• Device Catalogue Number: 5955450
• Device Lot Number: HUGX0492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/03/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2022
• 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