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

Catalog Number 0010301

Device Problems Material Separation (1562); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2017

Event Type  malfunction  

Manufacturer Narrative

The sample has been received, however at this time the evaluation is in progress and root cause has not been determined. A supplemental mdr will be sent when the evaluation has been completed. 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

It was reported that prior to use of a bard ventralex hernia patch the ring was found to have been detached from the patch. Another device was used to complete the procedure, there was no injury to the patient.

Manufacturer Narrative

This is an addendum to the initial mdr as the sample evaluation has been completed. Visual examination at unaided eye and under magnification was conducted. Initial observation confirms the ring was intact within the containment sleeve and the containment sleeve being partially separated from the patch. It was observed that the end sew line was not locked causing the loose monofilament. In addition, the condition of missing stitches due to loose monofilament at the end of sewing pattern was observed. This is the cause of the containment sleeve to partially separate from the patch. Therefore, the condition of the returned sample is confirmed as being related to the manufacturing process. As a result of this complaint the proper execution of visual inspections for sewing defects was discussed and reinforced to the manufacturing line operators. A review of the manufacturing records found that the lot was manufactured to specification with no anomalies noted.

• Brand Name: MESH -VENTRALEX
• 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 berg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 6322369
• MDR Text Key: 67231694
• Report Number: 1213643-2017-00092
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K132441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 03/03/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/28/2019
• Device Catalogue Number: 0010301
• Device Lot Number: HUAR2008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial