MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 AVITENE; 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	08/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during an unknown procedure, foreign material like hair was found while opening the package of avitene.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, upon opening the avitene package, a hair like foreign material was observed.Photo provided shows foreign material (hair/black) laying on top of the avitene ultrafoam.Based on visual inspection of the returned sample, the alleged hair has the features of a human hair and measures approximately 5 mm long.Based on the investigation performed, the confirmed hair likely presented during the manufacturing process.An awareness training was performed to the operators on gowning and other manufacturing related processes deemed necessary.A review of manufacturing records was performed and found that the device was manufactured to specification.To date, this is the only reported complaint for this lot of (b)(4) released for distribution in jan, 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.

• Brand Name: AVITENE
• 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: 17736330
• Report Number: 1213643-2023-00332
• Device Sequence Number: 5493251
• 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,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/18/2023

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: 12/28/2025
• Device Catalogue Number: 1010090
• Device Lot Number: WBGZ0021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2023
• 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