MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. AVITENE; AGENT, ABSORBABLE, HEMOSTATIC, COLLAGEN BASED

Catalog Number	1010150
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No conclusions can be made at this time as to the cause of the reported problem experienced.The subject product sample was discarded after attempted use and was not returned for evaluation.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date, this is the only reported complaint for the subject lot of 234 units manufactured in january of 2017.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.Device was not returned.
Event or Problem Description
It was reported by the user facility that the avitene hemostat did not come out powdery as was anticipated, but instead "like a block of cement".The avitene applied would not integrate properly and did not reduce the blood flow.Another hemostat, arista was applied to the site and worked appropriately.There was no patient injury that presented as a result of the reported problem with the avitene.

• Brand Name: AVITENE
• Common Device Name: AGENT, ABSORBABLE, HEMOSTATIC, COLLAGEN BASED
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 7905210
• Report Number: 1213643-2018-03277
• Device Sequence Number: 1473183
• Product Code: LMF
• UDI-Device Identifier: 00801741010484
• UDI-Public: (01)00801741010484
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P800002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2018

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: 11/28/2019
• Device Catalogue Number: 1010150
• Device Lot Number: WBAYND47
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2018
• Initial Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1