MAUDE Adverse Event Report: DAVOL INC. -1223089 AVITENE; AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED

Catalog Number	1010020
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	12/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, a black foreign object was found in avitene.Review of photo provided finds an area of discoloration (black in color) present within the avitene.Further evaluation of the provided photo is still ongoing, as such no conclusions have been made.When the evaluation is completed, a supplemental mdr will be submitted.To date, this is the only reported complaint for this manufacturing lot.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the results of sample evaluation.Based on the sample evaluation and investigation performed, the foreign material presented during the manufacturing process and the root cause is determined to be manufacturing related.The analysis concluded that the debris found can be generated from machinery bearings, bushings, seals, or other components as possible sources.Review of the risk documents finds this can possibly occur at multiple stages throughout the manufacturing process with controls in place to mitigate risk.A review of the manufacturing records confirms that the lot was manufactured to specification.Updated fields: b4, d9, g3, g6, h2, h3, 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.
Event or Problem Description
As reported, a black foreign object was found in the avitene in an unopened state before use.It was reported that there was no sign of package damage found.There was no patient injury.
Additional Manufacturer Narrative
As reported, a black foreign object was found in avitene.Review of photo provided finds an area of discoloration (black in color) present within the avitene.Further evaluation of the provided photo is still ongoing, as such no conclusions have been made.When the evaluation is completed, a supplemental mdr will be submitted.To date, this is the only reported complaint for this manufacturing lot.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, a black foreign object was found in the avitene in an unopened state before use.It was reported that there was no sign of package damage found.There was no patient injury.

• Brand Name: AVITENE
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED
• Manufacturer (Section D): DAVOL INC. -1223089; 160 new boston st.; woburn MA 01801
• 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: 21000994
• Report Number: 1213643-2024-00595
• Device Sequence Number: 9867685
• Product Code: LMF
• UDI-Device Identifier: 00801741000386
• UDI-Public: (01)00801741000386(17)270328(10)WBJQ0027
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N17600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2024

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: 1010020
• Device Lot Number: WBJQ0027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 12/23/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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