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

Catalog Number	0113230
Medical Device Problem Code	Unintended Ejection (1234)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, capsure fixation device misfired and deployed two fasteners at the same time.The subject device was discarded by the user facility.Based on the information available and without having the sample to evaluate, no conclusions can be made.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, the capsure fixation device misfires and deployed two fasteners.It was reported that the additional fastener was removed from the patient.The procedure was completed using a new device from a different lot number.It was reported the sample was discarded and there was no patient harm or 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: 21101566
• Report Number: 1213643-2024-00605
• Device Sequence Number: 13047960
• Product Code: GDW
• UDI-Device Identifier: 00801741094996
• UDI-Public: (01)00801741094996(17)250828(10)HUHW1512
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K142808
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/23/2024

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: 08/28/2025
• Device Catalogue Number: 0113230
• Device Lot Number: HUHW1512
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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