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

Catalog Number	AM0004
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, during set up of a procedure, one unit of arista ah flexitip applicator packaging/pouch was torn and unusable.Visual inspection of the returned sample revealed significant damage/sterile breach of the pouch, likely caused by an object impacting and cutting through the sterile barrier.This damage occurred when the pouched product was outside its carton.This was the only pouch from the product carton reported to exhibit this condition.Based on the investigation performed by the manufacturing the damage occurred after leaving the manufacturing site.When the product was damaged after distribution cannot be determined.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 manufacturing lot.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 set up of a procedure on (b)(6) 2025, one unit of arista ah flexitip applicator packaging/pouch was torn and unusable.A new unit was used for the procedure and the outer box was not damaged.This was the only damaged pouch in the product carton.

• Brand Name: ARISTA AH FLEXITIP APPLICATOR
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, NON 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: 22212795
• Report Number: 1213643-2025-00488
• Device Sequence Number: 8620353
• Product Code: LMG
• UDI-Device Identifier: 10801741044066
• UDI-Public: (01)10801741044066(17)260928(10)8132101
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P050038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2025

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: 09/28/2026
• Device Catalogue Number: AM0004
• Device Lot Number: 8132101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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