MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. ARISTA AH FLEXITIP XL-R APPLICATOR; AGENT, ABSORBABLE HEMOSTATIC, NON COLLAGEN BASED

Catalog Number	AM0010
Medical Device Problem Codes	Use of Device Problem (1670); Expiration Date Error (2528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2019
Type of Reportable Event	Malfunction
Additional 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 (05/28/2019) when provided to the facility on 02/06/2017.The expiration date is located on multiple layers of the packaging.This event is confirmed for user related.The ifu instructs the user "prior to initiating the procedure, visually inspect the package containing the flexitip xl-r applicator for any signs of damage.Used on patient and discarded.
Event or Problem Description
It was reported that the user facility was performing a minimally invasive ivor-lewis esophagectomy with gastric pull-up on (b)(6) 2019.At the close of the case, it was discovered that an expired flexi-tip applicator with arista hemostatic agent had been used during the case.There was no adverse patient outcome and no additional medical or surgical intervention required.

• Brand Name: ARISTA AH FLEXITIP XL-R APPLICATOR
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, NON COLLAGEN BASED
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 8777749
• Report Number: 1213643-2019-05937
• Device Sequence Number: 11422927
• Product Code: LMG
• UDI-Device Identifier: 00801741096808
• UDI-Public: (01)00801741096808
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P050038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/10/2019

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: 05/28/2019
• Device Catalogue Number: AM0010
• Device Lot Number: 5655201
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 65