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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 5954460
Device Problem Shelf Life Exceeded (1567)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/23/2018
Event Type  malfunction  
Manufacturer Narrative
As reported a device was supplied for use in the case beyond its labeled expiration date. The product was properly labeled with the expiration date at each level of packaging, as such there was no malfunction of the device itself. As the sterile pouch was intact at time of use it should not have presented any harm from placing in the body. The implant was removed and another used to complete the case. As such there is no potential for additional harm as a result of this use error. Photos provided of the product packaging confirm the reported lot number and the label expiration date on the sterile pouch to be 03/28/2017. Photos provided of the device show the implant was prepared for use by the surgeon as orientation markings and positioning sutures were applied. The problem was noted prior to attempted fixation, as there are no fixation points visible on the implant. A review of the manufacturing records was performed and found that the lot was manufactured to specification and labeled appropriately. Action is being taken locally to address the error in providing the device past its labeled expiration period. 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. No sample.
 
Event Description
An expired ventralight st product was supplied to the user facility on (b)(6) 2018 for use in a case. As reported the user noticed the label identified that the product expired march/2017 after placing it in the body. It was then removed and the mesh was not implanted. Another device was used to complete the case. There was no patient complication as a result of this use error.
 
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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 Key7436426
MDR Text Key105886703
Report Number1213643-2018-01105
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K101851
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 04/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/28/2017
Device Catalogue Number5954460
Device Lot NumberHUZC0648
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 Received03/23/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/26/2015
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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