MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 BARD FLAT MESH; SURGICAL MESH

Catalog Number	0112650
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	04/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, there was a hair in the bard flat mesh inner packaging.Photo evaluation finds what appears to be foreign material (hair-like) within the sterile pouch.Photo review does not assist in determining root cause.The sample is reported to be available for return, however, has not been received at this time.Based on the information reported and without having the physical sample to evaluate, no conclusions can be made.If/when the sample is returned and evaluation has been completed, a supplemental mdr will be submitted to document the results.Review of the manufacturing records was performed and found the lot 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, within the sterile package of a bard flat mesh, a foreign material that looked like a ¿hair¿ was noted to be present.It was reported that the issue was noticed during inventory inspection and was not used.There was no patient involvement.
Event or Problem Description
As reported, within the sterile package of a bard flat mesh, a foreign material that looked like a ¿hair¿ was noted to be present.It was reported that the issue was noticed during inventory inspection and was not used.There was no patient involvement.
Additional Manufacturer Narrative
As reported, there was a hair in the bard flat mesh inner packaging.Photo evaluation finds what appears to be foreign material (hair-like) within the sterile pouch.Photo review does not assist in determining root cause.The sample is reported to be available for return, however, has not been received at this time.Based on the information reported and without having the physical sample to evaluate, no conclusions can be made.If/when the sample is returned and evaluation has been completed, a supplemental mdr will be submitted to document the results.Review of the manufacturing records was performed and found the lot 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 photo evaluation results.Evaluation of the photo confirms the presence of a thread/hair like foreign material.Review determines the condition may have originated at manufacturing area during sealing/ inner packaging manufacturing process since thread like foreign matter was found inside the pouch.The condition could be caused by an incorrect cleanup process and was not detected during inspection performed during sealing package.Capa has previously been issued to identify possible causes and actions to mitigate the discrepancy of complaints related to biocontamination (hair).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: BARD FLAT MESH
• Common Device Name: SURGICAL MESH
• 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: 21901399
• Report Number: 1213643-2025-00346
• Device Sequence Number: 14508468
• Product Code: FTL
• UDI-Device Identifier: 00801741016509
• UDI-Public: (01)00801741016509(17)290528(10)HUJT1603
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• 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,Followup
• Report Date (Section B): 05/27/2025

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 Catalogue Number: 0112650
• Device Lot Number: HUJT1603
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2024
• 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