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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO; SURGICAL MESH
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DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO; SURGICAL MESH Back to Search Results
Catalog Number 5955680G
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/25/2023
Event Type  malfunction  
Event Description
As reported, prior to hydrating and rolling the ventralight st w/echo ps for use in a laparoscopic ventral repair it was noted that the inflation tube was not connected to the echo ps.The procedure was completed with a ventralight st mesh.There was no patient injury.
 
Manufacturer Narrative
It was reported that when attempting to use a ventralight st w/ echo, the inflation tube/balloon was found to be detached from the mesh.Photo review of 6 images provided: the images 1 and 2 show a product carton for a ventralight st w/ echo with the identifying label markers cat# 5955680g and lot# huhq0234.The carton has been crushed and is damaged.Images 3-6 show the ventralight st w/ echo product, in these photos you can see the inflation system has detached from the mesh.The connectors are present with one being damaged and one not attached to the mesh.The photos show the inflation tube is separated from the inflation balloon, it is not clear if this was cut or pulled out from the balloon.The condition of the product in the photos provided does not show the product to be in an as manufactured condition and appears to have been handled in preparation for use.Based on the information provided and without having the physical sample to evaluate no conclusions can be made.Review of manufacturing records shows the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in (b)(6) 2023.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 : not returned.
 
Manufacturer Narrative
It was reported that when attempting to use a ventralight st w/ echo, the inflation tube/balloon was found to be detached from the mesh.Photo review of 6 images provided: the images 1 and 2 show a product carton for a ventralight st w/ echo with the identifying label markers cat# 5955680g and lot# huhq0234.The carton has been crushed and is damaged.Images 3-6 show the ventralight st w/ echo product, in these photos you can see the inflation system has detached from the mesh.The connectors are present with one being damaged and one not attached to the mesh.The photos show the inflation tube is separated from the inflation balloon, it is not clear if this was cut or pulled out from the balloon.The condition of the product in the photos provided does not show the product to be in an as manufactured condition and appears to have been handled in preparation for use.Based on the information provided and without having the physical sample to evaluate no conclusions can be made.Review of manufacturing records shows the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 237 units released for distribution in april 2023.Addendum: this is an addendum to the initial mdr to document the sample evaluation results.Sample evaluation shows the mesh is detached from the balloon and is contaminated from handling.There is evidence that the device was handled and rolled in preparation for use.The inflation tube was returned and has been cut from the balloon.Three connectors are present in which two connectors were attached to the mesh and one having the coil stretched out as received.There are no manufacturing anomalies found.Dilation holes in the mesh indicate that the connectors were once attached to the mesh and align when the balloon is placed in its manufactured position.The most probable root cause is inadvertent damage to the device when being handled and rolled in preparation for use.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, prior to hydrating and rolling the ventralight st w/echo ps for use in a laparoscopic ventral repair it was noted that the inflation tube was not connected to the echo ps.The procedure was completed with a ventralight st mesh.There was no patient injury.
 
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Brand Name
VENTRALIGHT ST W/ ECHO
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 Key17959126
MDR Text Key326137425
Report Number1213643-2023-00372
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00801741201981
UDI-Public(01)00801741201981
Combination Product (y/n)N
Reporter Country CodeAG
PMA/PMN Number
K122436
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5955680G
Device Lot NumberHUHQ0234
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/26/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/19/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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