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

Catalog Number	0117010
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	11/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample evaluation is ongoing at this time.A supplemental mdr will be submitted once the evaluation is completed.Review of the manufacturing records was performed and found that the lot was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 204 units released for distribution in april 2023.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, after receiving the soft mesh for a procedure, the outer package was opened and found that there were unknown filaments (foreign material) within the inner package.There was no patient injury.
Additional Manufacturer Narrative
Sample evaluation is ongoing at this time.A supplemental mdr will be submitted once the evaluation is completed.Review of the manufacturing records was performed and found that the lot was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in april 2023.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the results of sample evaluation.Based on visual and manufacturing process evaluation performed the returned sample condition could be readily matched with a manufacturing-generated condition.Per investigation performed, it was determined that, condition may have originated at manufacturing area during sealing/ inner packaging manufacturing process since particulate is found to be within the sealed tyvek pouch.Our records continue to show there have been no other reported complaints to date for this lot.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, after receiving the soft mesh for a procedure, the outer package was opened and found that there were unknown filaments (foreign material) within the inner package.There was no patient injury.

• Brand Name: BARD SOFT 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: 18325261
• Report Number: 1213643-2023-00492
• Device Sequence Number: 12602203
• Product Code: FTL
• UDI-Device Identifier: 00801741030871
• UDI-Public: (01)00801741030871
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K052155
• 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): 12/18/2023

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: 0117010
• Device Lot Number: HUHQ1673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2023
• 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