MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALEX ST; SURGICAL MESH

Catalog Number 5950008

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2017

Event Type  malfunction  

Manufacturer Narrative

The sample was returned for evaluation in a hydrated state, the hydrogel coating was tacky to the touch and was noted to be balling up and separating from the mesh.There was no visible contamination on the mesh.Follow up with the contact was made regarding the condition of the returned sample and, it was stated that the sample was decontaminated prior to being returned for evaluation.The sample had been soaked in a decontamination solution for 20 minutes.The condition in which the mesh was received, with the hydrogel coating balling up is consistent with the sample being soaked in a liquid for a prolonged period of time.Due to the sample having been decontaminated by the user facility this complaint is inconclusive, as we are unable to evaluate the reported condition of the sample.It is possible that the issue reported by the user may have presented due to the hydrating technique used (a very quick dip prior to insertion).It is recommended in the instructions for use that the ventralex st hernia patch be completely immersed in sterile saline for 1-3 seconds immediately prior to placement in order to maximize the flexibility of the prosthesis.A manufacturing review that was performed and found that the lot was manufactured to specification.To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution on 05/16/2017.The information provided by bard 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 bard.

Event Description

The following was reported regarding an open umbilical/inguinal hernia repair procedure that was being performed using a bard ventralex st hernia patch.The contact reports that the surgeon does not hydrate this mesh at all prior to placement.When the surgeon attempted to unfold the mesh it was noted that portions of the hydrogel coating had come off.The mesh was removed and another was used without further issue.There was no patient injury.As initially reported the surgeon does not hydrate the bard ventralex st hernia patch.In follow up with the contact it was reported that the mesh was hydrated with a very quick dip prior to insertion.

• Brand Name: VENTRALEX ST
• 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: 6802039
• MDR Text Key: 83063188
• Report Number: 1213643-2017-00512
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031489
• UDI-Public: (01)00801741031489(17)190428(10)HUBP2359
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2019
• Device Catalogue Number: 5950008
• Device Lot Number: HUBP2359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2017
• 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
• Patient Age: 15 YR