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

Catalog Number 0113230

Device Problems Use of Device Problem (1670); Expiration Date Error (2528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The user facility reported that they used an expired capsure fixation device during a procedure.The labeled expiration date on the product was (b)(6) 2018.Per our records review the product was provided to the facility on (b)(6) 2018.The expiration date is identified on each level of the packaging.This event is confirmed to be solely a use related error.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 capsure fixation device was used past the labeled expiration date of (b)(6) 2018 on the patient.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: 7960459
• MDR Text Key: 123533303
• Report Number: 1213643-2018-03516
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 00801741094996
• UDI-Public: (01)00801741094996
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2018
• Device Catalogue Number: 0113230
• Device Lot Number: HUAV1250
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2016
• 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