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

Catalog Number	1161015
Medical Device Problem Code	Shelf Life Exceeded (1567)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported by the facility the expired device was implanted in error.A review of our records show that the device was provided to the facility prior to the date of expiry (02/28/2018).This event is confirmed for use related.The instructions-for-use instructs the user to inspect the package prior to use.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.Remains implanted.
Event or Problem Description
It was reported that an emergency case was performed on (b)(6) 2018.During this procedure a davol xenmatrix graft was placed.As reported following the procedure while processing the records it was identified that the labeled expiration date of the implanted device was 02/28/2018.Per materials manager, the unit was from the hospital inventory.The risk manager confirmed the use error on the part of the facility.The risk manager was informed that there was no test data to support a longer shelf life for the product.Hospital planned to inform the patient of the error that occurred.At this time there has been no patient complications or medical intervention.

• Brand Name: XENMATRIX
• Common Device Name: PORCINE SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 7504361
• Report Number: 1213643-2018-01412
• Device Sequence Number: 283749
• Product Code: FTM
• UDI-Device Identifier: 00801741031380
• UDI-Public: (01)00801741031380
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K081272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/10/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 1161015
• Device Lot Number: HUAQ0052
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 05/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1