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

Catalog Number	SM0002-USA
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, bard/davol arista ah powder did not achieve hemostasis when used during the procedure.The subject product was discarded by the user facility.Review of manufacturing records confirms product lot was manufactured to specification.No indication of a manufacturing related cause for the event reported.The reported condition of material clumping as presenting may not prevent the product from performing as intended.At this time no definitive conclusion can be made.The administration section of the instruction for use (ifu) states " a liberal amount of arista¿ ah should be applied to the bleeding site followed by pressure until hemostasis is achieved." additionally, the precautions section of the ifu states "arista¿ ah is intended to be used in a dry state.Contact with saline or antibiotic solutions prior to achieving hemostasis will result in loss of hemostatic potential.".
Event or Problem Description
As reported, during a cardiac surgery on (b)(6) 2021 bard/davol arista ah 3g us was used on the patient.The arista was not in a powdery form, as is normal.It was identified as cake-like, clumpy, and thick.The surgeon utilized this during surgery but hemostasis was not achieved.As reported, the arista ah material was in a dry state and did not come in contact with any fluids before deployment.Another from the same lot was opened, deployed onto a surgical towel and noted the same consistency.Another arista ah was used without issue.There was no patient impact as a result of this event.As the arista ah used did not achieve hemostasis a malfunction mdr is submitted to document the event.

• Brand Name: ARISTA AH
• 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
• MDR Report Key: 12058355
• Report Number: 1213643-2021-20158
• Device Sequence Number: 3870473
• Product Code: LMG
• UDI-Device Identifier: 00801741044106
• UDI-Public: (01)00801741044106
• 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: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/08/2021

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: 02/28/2026
• Device Catalogue Number: SM0002-USA
• Device Lot Number: 6453501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other