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

Catalog Number 0115321

Device Problems Off-Label Use (1494); Product Quality Problem (1506)

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

Event Date 08/23/2021

Event Type  malfunction  

Manufacturer Narrative

As reported, upon opening a bard/davol 3dmax mesh, the inner package was noted to be resterilized and repacked.The subject device is not available for evaluation.A photo of the packaging was provided.Depicted in the photos is a 3dmax product carton that is opened with the inner pouch shown.The inner pouch is inside of a sterilization pouch (which is not part of the bd product packaging) and a strip of tape (approximately 2 inches long) with the word ¿gas¿ in greenish print as part of the tape.Hand-written on the sterilization pouch is a ¿xi (b)(6) 2019¿.Visual examination of the photos provided confirm that the product is not in the as manufactured condition.This lot was released from bd manufacturing for distribution in april 2017.Review finds no other complaints of this nature have been reported for this lot of 339 units.Based on the date written of the sterilization pouch, the reported repackaging and resterilization was done more than 2 years after bd manufacturing lot release.We have been unable to determine who repackaged/resterilized.It has been reported that the local south african distribution warehouse, performs a distribution and warehousing function only.Based on the available information potential causes could be related to a local customer return at the distribution warehouse level or this user facility received the product through another distribution channel, such as interfacility transaction, for which we cannot determine.The warnings section of the instruction-for-use (ifu) supplied with the device states, "the device has been designed for single use only.Reuse, reprocessing, resterilization or repackaging may compromise the structural integrity and/or essential material and design characteristics that are critical to the overall performance of the device and may lead to device failure which may result in injury to the patient.Reuse, reprocessing, resterilization or repackaging may also create a risk of contamination of the device and/or cause patient infection or cross infection, including, but not limited to, the transmission of infectious diseases from one patient to another.Contamination of the device may lead to injury, illness or death of the patient or end user.".

Event Description

As reported, while preparing for a laparoscopic inguinal hernia repair procedure, when the bard/davol 3dmax mesh was opened, the or nurse noted that the mesh was "resterilized and repacked dating back to (b)(6) 2019".As reported, the package was delivered through a distributor and was received by the facility between (b)(6) 2021 in good condition.The mesh was not used and another bard/davol 3dmax mesh was used to complete the procedure.There was no reported patient injury.

• Brand Name: 3DMAX
• 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: 12500415
• MDR Text Key: 273630222
• Report Number: 1213643-2021-20335
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741030765
• UDI-Public: (01)00801741030765
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K081010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2022
• Device Catalogue Number: 0115321
• Device Lot Number: HUBP2348
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2017
• 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