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

Catalog Number	SM0005-USA
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported the surgeon applied the arista in small amounts in multiple areas and manipulated, applying pressure with a wet cottonoid.In this manner the product did not work as intended.The precautions section of the instructions-for-use supplied with the device state, "arista 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".As reported this was the surgeons first use of the product.Based on the information provided this was a use of device issue (failure to follow instructions).Review of the device history records confirmed the product was manufactured to specification.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.Used on patient, not returned.
Event or Problem Description
It was reported per the bd sales rep.That about a month ago, a surgeon used arista for the first time in a cervical/spine procedure.The case was considered a lean case, with no existing infection.The arista powder (1 gram) was deployed in small amounts in multiple areas and manipulated, applying pressure with a wet cottonoid (neuro patty).The arista powder then became firm and pellet like and hemostasis was not achieved.The arista was removed from the patient and another form of hemostatic agent was used.The case was completed with no impact or harm to the patient as a result of the reported event.

• Brand Name: ARISTA AH ABSORBABLE HEMOSTAT
• 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: 7888833
• Report Number: 1213643-2018-03161
• Device Sequence Number: 1940229
• Product Code: LMG
• UDI-Device Identifier: 00801741044120
• UDI-Public: (01)00801741044120
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/19/2018

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: 12/28/2022
• Device Catalogue Number: SM0005-USA
• Device Lot Number: 5912301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1