MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 CAPSURE; STAPLE, IMPLANTABLE

Catalog Number	0113215
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	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during the procedure, upon opening the package, a "white foreign substance" was observed on the handle of the capsure fixation device.Consequently, the product was not used, and the procedure was completed with a new device.The product box was fully sealed prior to opening, and there was no patient contact with the affected device.
Additional Manufacturer Narrative
As reported, during procedure after opening the package it was noted that, "a white foreign substance" was found on capsure fixation device handle.The sample is said to be available for evaluation; however, at this time it has not been received.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.
Additional Manufacturer Narrative
As reported, during procedure after opening the package it was noted that, "a white foreign substance" was found on capsure fixation device handle.The sample is said to be available for evaluation; however, at this time it has not been received.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: this is an addendum to the initial mdr submitted to document the sample evaluation results.Evaluation of sample device confirms the presence of "foreign" substance (white in color) visible on the capsure device trigger.The foreign matter-white stain on device trigger is not identified as being part of the components or material used in the manufacturing process.No discrepancies were reported either at the final assembly or the packaging/sealing inspection process that could be related to condition evaluated.How or when the white colored material presented on the handle cannot be determined but is mostly likely to have presented after the manufacturing process.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 the procedure, upon opening the package, a "white foreign substance" was observed on the handle of the capsure fixation device.Consequently, the product was not used, and the procedure was completed with a new device.The product box was fully sealed prior to opening, and there was no patient contact with the affected device.

• Brand Name: CAPSURE
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 23769138
• Report Number: 1213643-2025-01178
• Device Sequence Number: 16105928
• Product Code: GDW
• UDI-Device Identifier: 00801741094989
• UDI-Public: (01)00801741094989(11)250303(17)270228(10)HUKP1496
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142808
• 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): 12/16/2025

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 Catalogue Number: 0113215
• Device Lot Number: HUKP1496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2025
• 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