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

Catalog Number	SM0005-USA
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	12/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As report, during a procedure foreign material (long hair) was found in the sprayed powder which was inside the sterile package of (b)(6).The product box was completely sealed before opening and there was no damage to the inner package.There was no patient injury.
Additional Manufacturer Narrative
As reported, foreign material (long hair) was found in the sprayed powder of (b)(6), which was inside the sterile package.Based on the information available and without having the sample to evaluate, no conclusions can be made.A review of the manufacturing records was performed and found that the lot was manufactured to the 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.
Event or Problem Description
As report, during a procedure foreign material (long hair) was found in the sprayed powder which was inside the sterile package of arista ah.The product box was completely sealed before opening and there was no damage to the inner package.There was no patient injury.
Additional Manufacturer Narrative
As reported, foreign material (long hair) was found in the sprayed powder of arista ah, which was inside the sterile package.Based on the information available and without having the sample to evaluate, no conclusions can be made.A review of the manufacturing records was performed and found that the lot was manufactured to the specification.Addendum: h11: this is an addendum to the initial mdr submitted to correct the medical device catalog number.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.

• Brand Name: ARISTA AH
• 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: 24401061
• Report Number: 1213643-2026-00189
• Device Sequence Number: 9730443
• Product Code: LMG
• UDI-Device Identifier: 00801741044120
• UDI-Public: (01)00801741044120(17)290728(10)8243201
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P050038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2026

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: SM0005-USA
• Device Lot Number: 8243201
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2024
• 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