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

Catalog Number 5955810

Device Problems Inflation Problem (1310); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

No conclusion can be made.The sample was discarded by the user facility and therefore unavailable for evaluation.Based on the information provided root cause is undetermined.To date this is the only reported complaint for this production lot of (b)(4) units released for distribution in january, 2017.A review of the manufacturing records was performed and found that the lot was manufactured to specification.

Event Description

It was reported that during a laparoscopic ventral hernia repair using a bard ventralight st w/ echo ps the inflation device tubing came out and the user was unable to inflate the balloon.To work around the issue, the surgeon put 4 sutures in the mesh, brought them out through the skin and tacked the mesh.Customer contact states that the mesh was able to be successfully implanted and the device was discarded by the facility.As reported there was no injury or impact to the patient.

• Brand Name: VENTRALIGHT ST W/ ECHO
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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: laura sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 8085904
• MDR Text Key: 128314459
• Report Number: 1213643-2018-04064
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031786
• UDI-Public: (01)00801741031786
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2018
• Device Catalogue Number: 5955810
• Device Lot Number: HUAY2119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1