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

Catalog Number	0113215
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, upon opening the package, a loose screw of the capsure fixation device was observed.The physical sample has been received for evaluation.Preliminary visual evaluation and the photo provided confirmed, there is a loose component that appears to be pin within the device packaging.Further review of the returned sample is currently ongoing, as such no conclusions have been made.When the sample evaluation is completed, a supplemental mdr will be submitted.A review of the manufacturing records was performed and found that the lot was manufactured to 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 reported, upon opening the package inside the operating room, a loose screw of the capsure fixation device was observed.It was reported that the device was not used, and another device was used to complete the procedure.The outer packaging was intact, and the inner packaging was properly sealed before opening.
Additional Manufacturer Narrative
As reported, upon opening the package, a loose screw of the capsure fixation device was observed.The physical sample has been received for evaluation.Preliminary visual evaluation and the photo provided confirmed, there is a loose component that appears to be pin within the device packaging.Further review of the returned sample is currently ongoing, as such no conclusions have been made.When the sample evaluation is completed, a supplemental mdr will be submitted.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Addendum: this is an addendum to the initial mdr submitted to document the sample evaluation results.Based on the sample evaluation conducted, the root cause was confirmed to be manufacturing-related.Evaluation of the returned sample finds that during manufacturing assembly activities, an extra component (captive pin) was not detected during packaging/sealing activities, as it could fall off during further device handling process.General awareness was conducted to fixation (capsure) manufacturing personnel to enforce device visual inspection/ correct assembly process following current procedure requirements.Updated fields: b4, 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, upon opening the package inside the operating room, a loose screw of the capsure fixation device was observed.It was reported that the device was not used, and another device was used to complete the procedure.The outer packaging was intact, and the inner packaging was properly sealed before opening.

• 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: 23485569
• Report Number: 1213643-2025-01073
• Device Sequence Number: 10526719
• Product Code: GDW
• UDI-Device Identifier: 00801741094989
• UDI-Public: (01)00801741094989(11)240806(17)260728(10)HUJV0156
• 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): 11/07/2025

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: 07/28/2026
• Device Catalogue Number: 0113215
• Device Lot Number: HUJV0156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2024
• 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