MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 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	04/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, during preparation of the avitene flour with saline solution, a hair-like foreign material was observed.Photo provided by the customer shows what appears to be a strand of hair or fiber visible in the bottom of the tray containing the avitene flour.The subject device was returned for evaluation.The sample evaluation confirms that what appears to look like a human hair, black in color, is present in the product.As reported, the foreign material was not noted as an out of box condition.At this time, it cannot be determined when the foreign material was introduced into the product, as such no conclusion can be made.No conclusions can be made as evaluation is ongoing at this time.When sample evaluation is completed, a supplemental mdr will be submitted to document the result of sample evaluation.Review of manufacturing records indicates the product was manufactured to specification with no indication of a manufacturing related cause for the event reported.To date, this is the only complaint reported for this manufacturing lot of 3990 units released for distribution in february, 2021.
Event or Problem Description
As reported, during an unknown procedure on (b)(6) 2022, during preparation of the bard/davol avitene flour with saline solution, a hair-like foreign material was found.There was no damage noticed on the outer package.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, during preparation of the avitene flour with saline solution, a hair-like foreign material was observed.Photo provided by the customer shows what appears to be a strand of hair or fiber visible in the bottom of the tray containing the avitene flour.The subject device was returned for evaluation.The sample evaluation confirms that what appears to look like a human hair, black in color, is present in the product.As reported, the foreign material was not noted as an out of box condition.At this time, it cannot be determined when the foreign material was introduced into the product, as such no conclusion can be made.No conclusions can be made as evaluation is ongoing at this time.When sample evaluation is completed, a supplemental mdr will be submitted to document the result of sample evaluation.Review of manufacturing records indicates the product was manufactured to specification with no indication of a manufacturing related cause for the event reported.To date, this is the only complaint reported for this manufacturing lot of 3990 units released for distribution in february, 2021.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the results of sample evaluation.As stated in the preliminary evaluation, the sample evaluation confirms what appears to look like a human hair, black in color, is present in the product.Review of manufacturing records/practices shows the operators are fully gowned during the entire manufacturing process.As reported, the foreign material was not noted as an out of box condition and it is unknown if the user was fully gowned prior to opening the product or how the product was handled.Based on the sample evaluation and investigation performed, the reported event was confirmed; however, it cannot be determined when/where the material was introduced into the package; root cause is undetermined.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, during an unknown procedure on 12-apr-2022, during preparation of the bard/davol avitene flour with saline solution, a hair-like foreign material was found.There was no damage noticed on the outer package.There was no reported patient injury.

• 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: 14318401
• Report Number: 1213643-2022-00203
• Device Sequence Number: 4587292
• Product Code: LMF
• UDI-Device Identifier: 00801741000386
• UDI-Public: (01)00801741000386
• 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,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2022

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: 01/28/2024
• Device Catalogue Number: 1010020
• Device Lot Number: WBFN0025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2021
• 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