MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX LIGHT; SURGICAL MESH

Catalog Number	0117320
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the edge of the 3dmax light mesh was noted to be broken.This was reported as an out of box event.Photo provided shows a 3dmax light mesh within its clamshell tray.Due to the mesh being inside the clamshell tray the edges of the mesh are not clearly visible.Photo does not assist in determining root cause.As reported the sample is being returned for evaluation; however, has not been received.At this time, no conclusions can be made.If/when the sample is returned and evaluated a supplemental mdr will be submitted.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 june 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, when the nurse opened the sterile packing of the 3dmax light mesh for installation, they noticed that the edge of the mesh was broken and was not used.It was reported that the box was completely sealed and there was no damage noted on inner or outer package.
Event or Problem Description
As reported, when the nurse opened the sterile packing of the 3dmax light mesh for installation, they noticed that the edge of the mesh was broken and was not used.It was reported that the box was completely sealed and there was no damage noted on inner or outer package.
Additional Manufacturer Narrative
As reported, the edge of the 3dmax light mesh was noted to be broken.This was reported as an out of box event.Photo provided shows a 3dmax light mesh within its clamshell tray.Due to the mesh being inside the clamshell tray the edges of the mesh are not clearly visible.Photo does not assist in determining root cause.As reported the sample is being returned for evaluation; however, has not been received.At this time, no conclusions can be made.If/when the sample is returned and evaluated a supplemental mdr will be submitted.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 june 2021.H10: addendum: this is an addendum to the initial mdr to document the sample evaluation results.Evaluation of the sample shows the mesh has been visibly handled indicated by body fluid contamination on the mesh.Evaluation confirms there is a tear in the edge seal which starts at the seal and travels into the mesh.A tear of this nature would not be an out of the box condition and can present with forces applied to mesh.No manufacturing anomalies were found.Based on sample evaluation and investigation performed, the likely root cause is forces applied to the mesh during user/device interface.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.

• Brand Name: 3DMAX LIGHT
• 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: 18958284
• Report Number: 1213643-2024-00097
• Device Sequence Number: 9345974
• Product Code: FTL
• UDI-Device Identifier: 00801741031052
• UDI-Public: (01)00801741031052
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K091659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2024

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 Expiration Date: 04/28/2026
• Device Catalogue Number: 0117320
• Device Lot Number: HUFS0333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2024
• Supplement Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2021
• 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