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

Catalog Number 0117310

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 06/16/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned for evaluation.The foreign material noted by the customer is not identified to be an insect.Visual evaluation finds a small particulate that appears to be a residual fiber or cardboard material on the outside of the sterile package.The particulate is located above the seal of the sterile pouch.The sterile barrier of the product remains intact and the particulate is not in contact with the implant.Based on the sample evaluation and investigation performed, the root cause of the reported event is determined to be manufacturing process related.To date, this is the only reported complaint from this manufacturing lot of 711 units released for distribution in december, 2021.Sample evaluated.

Event Description

As reported, when opening the 3dmax light mesh package during a hernia repair procedure on (b)(6) 2022, it was found that what appeared to be an insect was in the package.The device was not used in the case.As reported, there was no damage noted on the outer package/inner package.Another 3dmax light was used to complete the procedure.There was no 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: 14961786
• MDR Text Key: 295705092
• Report Number: 1213643-2022-00497
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031021
• UDI-Public: (01)00801741031021
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 06/20/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 0117310
• Device Lot Number: HUFY1271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2022
• Initial Date FDA Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/18/2021
• 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