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

Catalog Number 0117311

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2022

Event Type  malfunction  

Manufacturer Narrative

As reported, a hole was noted in the inner package of the 3dmax light mesh.The sample is not available for return, however, photos were provided.Evaluation of the photos, shows the mesh product packaging was opened and the inner sterile tyvek pouch has a visible indentation and discoloration of the tyvek.The tyvek appears to have seen an outside in, force which has pushed the material inwards.Evaluation of the images cannot determine if there is a breach of the sterile barrier due to low quality of the images.Root cause is undetermined.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in february, 2022.Not returned.

Event Description

As reported, upon opening the product package of a bard/davol 3dmax light mesh on (b)(6) 2022, there was a hole noted in the tyvek side of the sterile pouch.As reported, the product was received without any damage to outer package and the box was completely sealed prior to opening for the case.There was no reported patient injury.

Manufacturer Narrative

As reported, a hole was noted in the inner package of the 3dmax light mesh.The sample is not available for return, however, photos were provided.Evaluation of the photos, shows the mesh product packaging was opened and the inner sterile tyvek pouch has a visible indentation and discoloration of the tyvek.The tyvek appears to have seen an outside in, force which has pushed the material inwards.Evaluation of the images cannot determine if there is a breach of the sterile barrier due to low quality of the images.Root cause is undetermined.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the results of sample evaluation.The pouch and secondary packaging were visually examined by our principle packaging engineer.A hole was identified in the tyvek portion of the sterile pouch.The hole was visually examined under magnification.The hole was found to be an inside-out failure.Meaning the stress that created the hole was not caused by something penetrating into the sterile package.The internal packaging and the product itself, could not have made the hole that was found, as nothing is the size or shape.The product carton showed no visible sign of damage that could indicate external forces that would have caused the hole in the inner sterile pouch.While a definitive cause could not be established it appears the hole most likely presented when opening the tyvek pouch and the condition identified after opening the pouch.This would account for an inside-out hole and nothing inside the package puncturing the package.No manufacturing anomalies were found.To date, this remains the only reported complaint from this manufacturing lot of 1,276 units released for distribution in february 2022.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 Description

As reported, upon opening the product package of a bard/davol 3dmax light mesh on 14-jun-2022, there was a hole noted in the tyvek side of the sterile pouch.As reported, the product was received without any damage to outer package and the box was completely sealed prior to opening for the case.There was no reported patient injury.

• Brand Name: 3DMAX LIGHT
• Type of Device: 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: 14914600
• MDR Text Key: 295335885
• Report Number: 1213643-2022-00487
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031038
• UDI-Public: (01)00801741031038
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K091659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2023
• Device Catalogue Number: 0117311
• Device Lot Number: HUGN0360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other