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

Catalog Number	1020010
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	03/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the avitene flowable was unsuccessful in controlling the bleeding.The subject device was not available for evaluation.As reported, the flowable was mixed with 5ml of saline, which would have made it less viscous and have a thinker consistency.The staff also threw away the connector and tip.It was also reported that a 14g tip (1.6mm) was used, which is smaller than the supplied and intended tip (3mm).Based on the information provided and investigation performed the reported event is determined to be use related.No lot number has been provided; therefore, a review of the manufacturing records is not possible.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, during posterior longitudinal ligament (pll) dissection, the avitene flowable was unsuccessful in controlling the bleeding.The surgeon applied flowable three times, after the third unsuccessful attempt with flowable, they used a non-bd product to complete the procedure.This failure caused a delay in the procedure.It was confirmed that the patient was not heparinized during the procedure.There was no patient harm or 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: 24690269
• Report Number: 1213643-2026-00365
• Device Sequence Number: 15884466
• Product Code: LMF
• UDI-Device Identifier: 00801741223105
• UDI-Public: (01)00801741223105
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: N17600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/12/2026

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: 1020010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Male