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

Catalog Number	0113230
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	11/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, during ipom procedure there was blood stain marks noted on the firing handle of the capsure fixation device.The sample is being returned for evaluation but has not yet been received.A photo was provided confirming the presence of "stains" red/brownish in color on the device.However, photos do not assist in determining root cause.Based on the information provided and not having the physical sample to evaluate no conclusions can be made.If/when the sample is returned and evaluated a supplemental mdr will be submitted to document the evaluation results.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.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 ipom procedure there was blood stain marks noted on the firing handle of the capsure fixation device.The product packaging was intact, and the inner packaging was completely sealed before opening.Another device was used to complete the procedure.There was no patient injury.
Additional Manufacturer Narrative
As reported, during ipom procedure there was blood stain marks noted on the firing handle of the capsure fixation device.The sample is being returned for evaluation but has not yet been received.A photo was provided confirming the presence of "stains" red/brownish in color on the device.However, photos do not assist in determining root cause.Based on the information provided and not having the physical sample to evaluate no conclusions can be made.If/when the sample is returned and evaluated a supplemental mdr will be submitted to document the evaluation results.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.Addendum: this is an addendum to the initial mdr submitted to document the sample evaluation results.Evaluation of the sample confirms the presence of "foreign" substance visible on the capsure device housing.The substance does not appear to be blood.Based on complaint report and sample device evaluation, foreign matter-brown stains found on device are 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 brown colored material presented on the handle cannot be determined but is mostly likely to have presented after the manufacturing process.Updated fields: b4, d9, g3, g6, h2, h3, h6, h10.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 ipom procedure there was blood stain marks noted on the firing handle of the capsure fixation device.The product packaging was intact, and the inner packaging was completely sealed before opening.Another device was used to complete the procedure.There was no patient injury.

• 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: 23829331
• Report Number: 1213643-2025-01235
• Device Sequence Number: 5093390
• Product Code: GDW
• UDI-Device Identifier: 00801741094996
• UDI-Public: (01)00801741094996(17)251128(10)HUHZ1070
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025

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: 11/28/2025
• Device Catalogue Number: 0113230
• Device Lot Number: HUHZ1070
• 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: 11/28/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2024
• 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