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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST MESH SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST MESH SURGICAL MESH Back to Search Results
Catalog Number 5954680
Device Problems Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385); Device Damaged by Another Device (2915)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/29/2017
Event Type  Malfunction  
Manufacturer Narrative

The sample evaluation found that the outer carton was damaged with a visible slice which penetrated into the inner packaging. The inner foil pouch was removed and it was confirmed that a slice was visible in the foil pouch causing a breach in sterility. The slice found in the inner foil pouch corresponds to the location of the visible slice in the outer carton. The slice went clean through both sides of the foil pouch and an indentation was created in the carton underneath the foil pouch were the slice was located. The sample evaluation indicates that the damage to the packaging most likely occurred sometime after distribution, and did not occur when in bard control. It appears that the slice found in the product packaging was likely caused by a sharp object, i. E. A box cutter, with applied force during removal from a shipper box, that penetrated through the outer carton and sliced the inner foil pouch. This complaint is confirmed for breach in sterile barrier, use related. To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution on (b)(6) 2017. The warning section of the instructions for use instructs the user to inspect the packaging prior to use, this action would most likely ensure that the user would be able to identify a sterility breach in the packaging prior to use on the patient, as happened in this incident. The information provided by bard 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 bard. Due to eu privacy requirements patient identifiers cannot be provided.

 
Event Description

It was reported that on (b)(6) 2017 while opening a bard ventralight st patch for a case it was noted that the foil pouch, housing the mesh, had a clean slice towards the top of the packaging. As reported the customer did not identify any damage to the outer packaging carton. Another ventralight st patch was used to complete the procedure and there was no injury to the patient.

 
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Brand NameVENTRALIGHT ST MESH
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
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
laura sundberg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key6876428
MDR Text Key86632367
Report Number1213643-2017-00604
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK101851
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 09/19/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/19/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2019
Device Catalogue Number5954680
Device LOT NumberHUBP1146
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/15/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/29/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/11/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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