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	06/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, a cotton like foreign material was noted in the sterile package of capsure fixation device.There was no reported patient injury.The subject device is said to be available for evaluation, however, at this time has not been received.Based on the information available and without having the sample to evaluate, no conclusions can be made.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 supplemental emdr is submitted to document the sample evaluation result.Sample evaluation confirmed that a "foreign" material (white in color) visible within the blister tray.Based on sample and manufacturing process evaluation performed, a definitive cause cannot be determined.Per the evaluation conducted, foreign matter found inside device tray is not identified as been part of the components or material used and is not representative of the device during the manufacturing process.Nevertheless, awareness was provided to all appropriate personnel.Note, the manufacturing date (17-dec-2024) is considered to be a best estimate based on the lot release date.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 a laparoscopic hernia repair, a cotton like foreign material was noted to be present within the sterile package of capsure fixation device and it was not used.It was reported that the operation was carried out successfully using a different product.Per information provided, there was no damage to the exterior and the sample will be returned.There was no patient injury.
Event or Problem Description
As reported, during a laparoscopic hernia repair, a cotton like foreign material was noted to be present within the sterile package of capsure fixation device and it was not used.It was reported that the operation was carried out successfully using a different product.Per information provided, there was no damage to the exterior and the sample will be returned.There was no patient injury.
Additional Manufacturer Narrative
As reported, a cotton like foreign material was noted in the sterile package of capsure fixation device.There was no reported patient injury.The subject device is said to be available for evaluation, however, at this time has not been received.Based on the information available and without having the sample to evaluate, no conclusions can be made.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 605 units.Note, the manufacturing date (17-dec-2024) is considered to be a best estimate based on the lot release date.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.

• 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: 22519779
• Report Number: 1213643-2025-00639
• Device Sequence Number: 18300991
• Product Code: GDW
• UDI-Device Identifier: 00801741094989
• UDI-Public: (01)00801741094989(17)260928(10)HUJX1594
• 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,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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: 09/28/2026
• Device Catalogue Number: 0113215
• Device Lot Number: HUJX1594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2024
• 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