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

Catalog Number	1050050
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the physician used avitene ultrafoam during a procedure, but the product failed to achieve hemostasis effectively in application.
Additional Manufacturer Narrative
As reported, avitene ultrafoam failed to achieve effective hemostasis.Based on the limited information provided to date, no conclusion can be made as to why hemostasis was not achieved during the procedure with the use of the avitene ultrafoam product.A review of manufacturing records was performed and found that the device was manufactured to specification.Note, the date of event (b)(6) 2023 is considered to be a best estimate.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 physician used avitene ultrafoam during a procedure, but the product failed to achieve hemostasis effectively in application.The product was reported to have made contact with the patient body fluids.There was no harm to patient.It was reported that the surgeon completed the procedure with the same product.
Additional Manufacturer Narrative
As reported, avitene ultrafoam failed to achieve effective hemostasis.Based on the limited information provided to date, no conclusion can be made as to why hemostasis was not achieved during the procedure with the use of the avitene ultrafoam product.A review of manufacturing records was performed and found that the device was manufactured to specification.Addendum: h11: this supplemental mdr is submitted to report the provided additional information and to correct the previously estimated event date.Based on the additional information received, there is no change to the initial determination, no conclusion can be made.Updated fields: b4, b5, g3, g6, h2, h10, h11 corrected field: b3 (date of event) 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.

• Brand Name: AVITENE ULTRAFOAM
• 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: 17498043
• Report Number: 1213643-2023-00287
• Device Sequence Number: 6392163
• Product Code: LMF
• UDI-Device Identifier: 00801741010552
• UDI-Public: (01)00801741010552
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2023

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: 08/28/2024
• Device Catalogue Number: 1050050
• Device Lot Number: WBFU0041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2021
• 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