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

Catalog Number	SM0005-USA
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, small flecks of tan/brown specks were noted in arista ah powder.Image of brown colored particles present in arista ah powder is provided.The condition noted appears to be arista material but cannot be confirmed by images provided.Review of the returned lot samples is currently ongoing, as such no conclusions have been made.When the sample evaluation is completed, a supplemental mdr will be submitted.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 an unknown procedure of preclinical animal study, six (6) bellows of arista ah were opened and weighed prior to use.It was reported that small flecks of tan/brown specks were noted when the weighing the product.It was also reported that the powder was used without any issues noted.
Event or Problem Description
As reported, during an unknown procedure of preclinical animal study, six (6) bellows of arista ah were opened and weighed prior to use.It was reported that small flecks of tan/brown specks were noted when the weighing the product.It was also reported that the powder was used without any issues noted.
Additional Manufacturer Narrative
As reported, small flecks of tan/brown specks were noted in arista ah powder.Image of brown colored particles present in arista ah powder is provided.The condition noted appears to be arista material but cannot be confirmed by images provided.Review of the returned lot samples is currently ongoing, as such no conclusions have been made.When the sample evaluation is completed, a supplemental mdr will be submitted.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the lot sample evaluation results.Evaluation of returned lot sample confirmed the presence of brown particles inside the vials which were ¿browned¿ portions of the same or similar polysaccharide starch that makes up the bulk of the formulation.Other than the organic acid product, no foreign compounds were found.The discoloration likely occurred during heat and time while being sterilization via gamma irradiation.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only complaint for the reported lot of 15,380 units released for distribution in (b)(6) 2022.Updated fields: b4, g3, g6, h2, h3, h4, h6, h10.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.H3 other text : lot sample evaluated.

• 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
• 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: 18364362
• Report Number: 1213643-2023-00511
• Device Sequence Number: 15457476
• Product Code: LMG
• UDI-Device Identifier: 00801741044120
• UDI-Public: (01)00801741044120
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P050038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2023

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 Catalogue Number: SM0005-USA
• Device Lot Number: 8001101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2023
• Supplement Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2022
• 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