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	05/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, when the physician opened the package to use the capsure device, they found some debris inside.It was reported that there was no problem with the product itself, and the device was used and completed the surgery without any issues.There was no patient injury.
Additional Manufacturer Narrative
As reported, some debris was found inside the product package of the capsure device.Preliminary evaluation of the sample found a "foreign" material (white in color) visible within the blister tray.The foreign material has been taped within the blister tray by the user.Further review of the returned sample is currently ongoing.When the sample evaluation is complete, 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.
Additional Manufacturer Narrative
As reported, some debris was found inside the product package of the capsure device.Preliminary evaluation of the sample found a "foreign" material (white in color) visible within the blister tray.The foreign material has been taped within the blister tray by the user.Further review of the returned sample is currently ongoing.When the sample evaluation is complete, 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.This supplemental mdr is submitted to document the results of sample evaluation.Evaluation of the returned device confirmed the debris/contamination identified upon package opening in the blister tray was a broken pin which is part of the device handle cover.Based on the sample evaluation result and investigation performed, the root cause is determined to be manufacturing related.When the pin broken in process could not be determined.Awareness training was provided to appropriate manufacturing personnel.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, when the physician opened the package to use the capsure device, they found some debris inside.It was reported that there was no problem with the product itself, and the device was used and completed the surgery without any issues.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: 22296499
• Report Number: 1213643-2025-00507
• Device Sequence Number: 8893161
• Product Code: GDW
• UDI-Device Identifier: 00801741094989
• UDI-Public: (01)00801741094989(11)240712(17)260628(10)HUJU0616
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142808
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

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: 06/28/2026
• Device Catalogue Number: 0113215
• Device Lot Number: HUJU0616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2024
• 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