MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. CAPSURE FIXATION SYSTEM; STAPLE, IMPLANTABLE

Catalog Number 0113215

Device Problems Shelf Life Exceeded (1567); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

As reported the expired capsure fixation device was used in error.A review of our records shows that the device expired on 02/28/2018 and was used on (b)(6) 2018.A review of the distribution records showed this lot of (b)(4) units manufactured in may of 2016 was distributed from bard inventory from may of 2016 through january of 2017.This event is confirmed for use related.The ifu instructs the user to do not use beyond the expiration date of the product.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.Not returned.

Event Description

It was reported by the user facility that a capsure was used past the labeled expiration date of 02/28/2018 during a laparoscopic umbilical hernia repair after fixating a ventralight st mesh on (b)(6) 2018.It was confirmed that the capsure device that was used was from the hospital's inventory.As reported, there was no patient impact or any medical intervention.

• Brand Name: CAPSURE FIXATION SYSTEM
• Type of Device: STAPLE, IMPLANTABLE
• 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: anna smith ; 100 crossings blvd.; warwick, RI 02886 ; 4018258449
• MDR Report Key: 7582290
• MDR Text Key: 110713411
• Report Number: 1213643-2018-01862
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 00801741094989
• UDI-Public: (01)00801741094989
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 0113215
• Device Lot Number: HUAP1154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2016
• 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