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

Catalog Number 5954460

Device Problem Shelf Life Exceeded (1567)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2018

Event Type  malfunction  

Manufacturer Narrative

As reported a device was supplied for use in the case beyond its labeled expiration date. The product was properly labeled with the expiration date at each level of packaging, as such there was no malfunction of the device itself. As the sterile pouch was intact at time of use it should not have presented any harm from placing in the body. The implant was removed and another used to complete the case. As such there is no potential for additional harm as a result of this use error. Photos provided of the product packaging confirm the reported lot number and the label expiration date on the sterile pouch to be 03/28/2017. Photos provided of the device show the implant was prepared for use by the surgeon as orientation markings and positioning sutures were applied. The problem was noted prior to attempted fixation, as there are no fixation points visible on the implant. A review of the manufacturing records was performed and found that the lot was manufactured to specification and labeled appropriately. Action is being taken locally to address the error in providing the device past its labeled expiration period. 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. No sample.

Event Description

An expired ventralight st product was supplied to the user facility on (b)(6) 2018 for use in a case. As reported the user noticed the label identified that the product expired march/2017 after placing it in the body. It was then removed and the mesh was not implanted. Another device was used to complete the case. There was no patient complication as a result of this use error.

• 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: 7436426
• MDR Text Key: 105886703
• Report Number: 1213643-2018-01105
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K101851
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/17/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/28/2017
• Device Catalogue Number: 5954460
• Device Lot Number: HUZC0648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial