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

Catalog Number 0113116

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/25/2019

Event Type  malfunction  

Manufacturer Narrative

As reported the expired device was used in error.A review of our records shows that the device was well within the date of expiry (02/28/2019) when provided to the facility on 05/28/2017.The expiration date is located on multiple layers of the packaging.This event is confirmed for user related.The ifu instructs the user to do not use beyond the expiration date of the product.Discarded at user facility.

Event Description

It was reported that on (b)(6) 2019 a sorbafix fixation device was used beyond it's labeled expiration date of 02/28/2019 to fixate a hernia mesh.As reported, the device worked as intended and there were no visual defects noted on the device.Fixation was already completed before noting the expiration date.This was a product the hospital pulled from their own stock.There was no patient injury reported.

• Brand Name: SORBAFIX ABSORBABLE 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: 8518409
• MDR Text Key: 142082083
• Report Number: 1213643-2019-03047
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 00801741016707
• UDI-Public: (01)00801741016707
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 0113116
• Device Lot Number: HUBP2598
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2017
• 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