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

Catalog Number	0117014
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	03/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No conclusions can be made.Photos were provided of both sides of the tyvek sterile pouch.There is local language writing applied in black marker on the tyvek side of the sterile pouch, it is unknown when the writing was applied.A photo of the opposite side of the pouch shows the mesh within the open sterile pouch.There is clear black marker bleed-through from the other side of the pouch from the tyvek being written on with black marker.In the middle of the mesh or pouch there is a black discoloration visible.As there is clear marker bleed-through in other areas of the pouch and without having the physical sample to evaluate, it cannot be determined through the photo if the black discoloration in the center of the mesh/pouch is marker bleed-through or a large foreign material.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 released for distribution in oct, 2021.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.H3 other text : not returned.
Event or Problem Description
As reported, during laparoscopic surgery, when the surgeon opened the soft mesh package, a black foreign material was noted on the product.It was reported that there was no damage noted on the outer and inner package when received and the product box was completely sealed prior to opening.The surgeon did not use the mesh and the procedure was completed using another soft mesh.There was no reported patient injury.
Additional Manufacturer Narrative
No conclusions can be made.Photos were provided of both sides of the tyvek sterile pouch.There is local language writing applied in black marker on the tyvek side of the sterile pouch, it is unknown when the writing was applied.A photo of the opposite side of the pouch shows the mesh within the open sterile pouch.There is clear black marker bleed-through from the other side of the pouch from the tyvek being written on with black marker.In the middle of the mesh or pouch there is a black discoloration visible.As there is clear marker bleed-through in other areas of the pouch and without having the physical sample to evaluate, it cannot be determined through the photo if the black discoloration in the center of the mesh/pouch is marker bleed-through or a large foreign material.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 213 units released for distribution in oct, 2021.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report that the sample was received and to document the results of the sample evaluation.Evaluation of the returned sample finds there is no foreign material identified in or on the tyvek packaging, nor was there any foreign material identified on the soft mesh device.The black mark seen in the photo previously provided is no longer present within the packaging or on the mesh.Based on the sample evaluation and investigation performed, the reported event is inconclusive as there is no trace of a foreign material in or on the product and packaging components returned.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.H3 other text : sample evaluated.
Event or Problem Description
As reported, during laparoscopic surgery, when the surgeon opened the soft mesh package, a black foreign material was noted on the product.It was reported that there was no damage noted on the outer and inner package when received and the product box was completely sealed prior to opening.The surgeon did not use the mesh and the procedure was completed using another soft mesh.There was no reported 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: 16763679
• Report Number: 1213643-2023-00149
• Device Sequence Number: 3061525
• Product Code: FTL
• UDI-Device Identifier: 00801741030918
• UDI-Public: (01)00801741030918
• 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): 05/01/2023

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 Expiration Date: 08/28/2026
• Device Catalogue Number: 0117014
• Device Lot Number: HUFW0352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2021
• 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