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	11/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a laparoscopic ventral hernia repair procedure on (b)(6) 2022 using the bard/davol ventralight st w/echo ps after fixating the mesh and removing the balloon it was noted that one of the connectors was missing.It was reported that the surgeon searched for the connector but, could not find the missing component and believes that it remains in the patient.No additional intervention has been performed.There was no reported patient injury.
Additional Manufacturer Narrative
As reported the sample is not available for return.Based on the information provided and without having the sample to evaluate, no conclusions can be made.To date, this is the only reported complaint for this manufacturing lot.Not returned.
Additional Manufacturer Narrative
As reported the sample is not available for return.Based on the information provided and without having the sample to evaluate, no conclusions can be made.To date, this is the only reported complaint for this manufacturing lot.Addendum: this is an addendum to the initial mdr submitted to document the results of sample evaluation.Visual evaluation confirms that one purple connector is detached/missing from the balloon.Inspection of the location on the balloon where the connector would be present finds a tear in the balloon material.This allowed for the connector to detach.No manufacturing anomalies were found.Based on the sample evaluation and investigation performed, the most probable root cause is that the connector likely became caught up while removing the balloon from the patient inadvertently tearing the balloon.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 116 units released for distribution in march,2022 updated fields: b4, d9, g3, g6, h2, h3, h4, h6, h10.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 a laparoscopic ventral hernia repair procedure on (b)(6) 2022 using the bard/davol ventralight st w/echo ps after fixating the mesh and removing the balloon it was noted that one of the connectors was missing.It was reported that the surgeon searched for the connector but, could not find the missing component and believes that it remains in the patient.No additional intervention has been performed.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: 15968762
• Report Number: 1213643-2022-00787
• Device Sequence Number: 4938386
• Product Code: FTL
• UDI-Device Identifier: 00801741031731
• UDI-Public: (01)00801741031731
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K130968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2023

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: 01/28/2024
• Device Catalogue Number: 5955600
• Device Lot Number: HUGP0367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2022
• Supplement Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2022
• 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