MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 AVITENE WEB SHEETS; AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED

Catalog Number	1010090
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	11/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, during a surgical procedure, avitene contaminated with foreign material.Based on the information available and without having the sample to evaluate, no conclusions can be made.Review of manufacturing records confirms product was manufactured to specification.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 : not returned.
Event or Problem Description
As reported, the avitene hemostat was used during a surgical procedure.After applying avitene to the site, it was observed that a foreign material was present, immediately removed and another avitene was used to complete the procedure.As reported, "the foreign material appeared to be a piece of the avitene packaging" and no damage on the outer package was noted.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, during a surgical procedure, avitene contaminated with foreign material.Based on the information available and without having the sample to evaluate, no conclusions can be made.Review of manufacturing records confirms product was manufactured to specification.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the results of sample evaluation.Sample evaluation noted the surface of the foreign material has a diamond pattern on the surface.The avitene does not have a pattern it is a flat sheet.The tyvek lid has a square pattern.The tyvek lid was not cut and is not the source of the fm.Review of other materials in the cleanroom also show that there was no match to the diamond pattern of the ¿foreign material¿.As reported the fm was identified after applying avitene to the hemostatic site, and it was removed.As such it appears most probable that the fm was something used in the patient prior to placing the avitene.Possibly being a section of some other type of hemostat patch or material used to blot the site to clean the area.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in april 2023.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 : sample evaluated.
Event or Problem Description
As reported, the avitene hemostat was used during a surgical procedure.After applying avitene to the site, it was observed that a foreign material was present, immediately removed and another avitene was used to complete the procedure.As reported, "the foreign material appeared to be a piece of the avitene packaging" and no damage on the outer package was noted.There was no reported patient injury.

• Brand Name: AVITENE WEB SHEETS
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, 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: 18187351
• Report Number: 1213643-2023-00456
• Device Sequence Number: 6541679
• Product Code: LMF
• UDI-Device Identifier: 00801741010460
• UDI-Public: (01)00801741010460
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P800002
• 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): 11/23/2023

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 Expiration Date: 03/28/2026
• Device Catalogue Number: 1010090
• Device Lot Number: WBHQ0042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 01/05/2024
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2023
• 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