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

Catalog Number 5954680

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Based on not having the sample returned to evaluate, no conclusion can be made.A photo of the device in question was provided.A review of the photo shows an area with dark colored spots/stains.However the photo review does not help to determine when the issue occurred, nor does it help to determine what is causing the appearance of dark colored spots/stains (cosmetic or other).As reported the mesh was not used on a patient and the reported issue was noted to be an out-of-box condition.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Device evaluated by mfr? discarded.

Event Description

It was reported that when a bard ventralight st mesh was opened for a case there were stains on the mesh that looked like "blood stains".There was no patient involvement.

• Brand Name: VENTRALIGHT ST MESH
• 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: 8335524
• MDR Text Key: 136618246
• Report Number: 1213643-2019-00798
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031656
• UDI-Public: (01)00801741031656
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101851
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/13/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2020
• Device Catalogue Number: 5954680
• Device Lot Number: HUCN0229
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/22/2019
• Initial Date FDA Received: 02/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2018
• 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