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

Catalog Number 0117311

Device Problem Unsealed Device Packaging (1444)

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

Event Date 10/17/2022

Event Type  malfunction  

Manufacturer Narrative

As reported, the inner package of the 3dmax light mesh was open.The subject device was returned for evaluation.The carton had been opened and the sterile package also opened as received.The sterile tyvek pouch has clearly defined seal transfer present confirming it was fully at the time of manufacture, with no break of the sterile barrier.The implant is contained in the clamshell tray, unopened.The tray is not a sterile barrier once the pouch is opened.No manufacturing anomalies were found.The sterile package was manually opened fully at some time after distribution.Based on the received condition it appears the device was opened by the user facility before and placed back into the carton.Review of manufacturing records confirms product was manufactured to specification.This is the only complaint to date for this manufacturing lot of 1,215 units released for distribution in jun, 2022.Sample evaluated.

Event Description

As reported, on (b)(6) 2022 the customer noted the inner sterile package of the bard/davol 3dmax light mesh was in an open condition.It was reported that the outer box was completely sealed.Condition was noted prior to use and another device used to complete the procedure.There was no patient impact as a result of this event.

• 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: 15784474
• MDR Text Key: 304361780
• Report Number: 1213643-2022-00731
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031038
• UDI-Public: (01)00801741031038
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0117311
• Device Lot Number: HUGS1756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2022
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2022
• 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