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

Catalog Number	0117016
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	05/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported foreign material (hair) was found in the soft mesh when the package was opened.The physical sample has been returned for evaluation.The root cause investigation is currently ongoing.When the sample evaluation is completed, a supplemental emdr will be submitted.Review of manufacturing records shows the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(6) units released for distribution in oct 2023 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 opening the package of a bard soft mesh on 21-may-2024, a foreign material (hair) was stuck to the mesh itself.The device was not used on the patient, the procedure was completed by using a new device.There was no reported patient harm or injury.
Additional Manufacturer Narrative
As reported foreign material (hair) was found in the soft mesh when the package was opened.The physical sample has been returned for evaluation.The root cause investigation is currently ongoing.When the sample evaluation is completed, a supplemental emdr will be submitted.Review of manufacturing records shows the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(6) units released for distribution in oct 2023.Addendum: this supplemental mdr is submitted to document the sample evaluation results.Sample evaluation confirmed a hair like foreign matter was found on the soft mesh.Based on sample and manufacturing process evaluation performed, the root cause is confirmed as manufacturing related.Awareness notification was provided to all appropriate personnel.Our records continue to show there have been no other reported complaints to date for this lot of (b)(6) units released for distribution in oct 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 opening the package of a bard soft mesh on (b)(6) 2024, a foreign material (hair) was stuck to the mesh itself.The device was not used on the patient, the procedure was completed by using a new device.There was no reported patient harm or 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: 19511407
• Report Number: 1213643-2024-00296
• Device Sequence Number: 3456240
• Product Code: FTL
• UDI-Device Identifier: 00801741030932
• UDI-Public: (01)00801741030932
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2024

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 Catalogue Number: 0117016
• Device Lot Number: HUHV2156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2023
• 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