MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 ARISTA HEMADERM KIT; AGENT, ABSORBABLE HEMOSTATIC, NON COLLAGEN BASED

Catalog Number	ENT0001-2
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a procedure an arista hemaderm kit which had a labeled expiration date on (b)(6) 2024 was used in the patient on (b)(6) 2024.There was no reported patient injury, change in course of treatment, or any medical/surgical intervention due to the issue.
Additional Manufacturer Narrative
As reported, an expired arista hemaderm kit was inadvertently used beyond its labeled expiration date.The expiration date is included on the labeling of this product and is located on multiple levels of the packaging.This event is confirmed as a use related error, with no malfunction of the device.Note: section a through f - the information provided by bd 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 bd.
Additional Manufacturer Narrative
As reported, an expired arista hemaderm kit was inadvertently used beyond its labeled expiration date.The expiration date is included on the labeling of this product and is located on multiple levels of the packaging.This event is confirmed as a use related error, with no malfunction of the device.Addendum: h11: this supplemental mdr is submitted to include dhr results and to remove implant date which was inadvertently added in the initial mdr.Review of manufacturing records shows product was made to specification.Updated fields: b4, d9, g3, h2, h4 (device manufacture date), h6, h10, h11 corrected field: d6.A (medical device implant date) note: section a through f - the information provided by bd 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 bd.
Event or Problem Description
As reported, during a procedure an arista hemaderm kit which had a labeled expiration date on (b)(6) 2024 was used in the patient on (b)(6) 2024.There was no reported patient injury, change in course of treatment, or any medical/surgical intervention due to the issue.

• Brand Name: ARISTA HEMADERM KIT
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, NON COLLAGEN BASED
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): DAVOL INC. -1223089; 160 new boston st.; woburn MA 01801
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 20966123
• Report Number: 1213643-2024-00584
• Device Sequence Number: 8379337
• Product Code: QSY
• UDI-Device Identifier: 00801741044083
• UDI-Public: (01)00801741044083(17)240728(10)6459101
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K033666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2025

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: 07/28/2024
• Device Catalogue Number: ENT0001-2
• Device Lot Number: 6459101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown