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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX SURGICAL MESH Back to Search Results
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.
 
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Brand Name3DMAX
Type of DeviceSURGICAL 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 Key12500415
MDR Text Key273630222
Report Number1213643-2021-20335
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K081010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
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 Received09/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0115321
Device Lot NumberHUBP2348
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/19/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/20/2021 Patient Sequence Number: 1
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