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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. PERFIX PLUG SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. PERFIX PLUG SURGICAL MESH Back to Search Results
Catalog Number 0112760
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The sample evaluation confirms the reported condition of breach of sterility. A slice was found to be present in the outer carton and when the outer carton was opened the slice was found to have gone through the lid of the tyvek tray which contained the perfix plug device, confirming a breach of sterility. No manufacuturing anomalies were found. The slice was likely caused by a sharp object, i. E. Box cutter or other type of blade, used during the removal from a shipper box that penetrated through the packaging. When the damage occurred cannot be determined. To date this is the only reported complaint for this production lot of (b)(4) units released for distribution in september, 2018. A review of the manufacturing records was performed and found that the lot was manufactured to specification. There was no patient involvement.
 
Event Description
As reported per customer contact: the perfix plug was received by the materials manager who opened the shipping package (by hand) and noted the inner product box to have a slit in it. Contact reports the slit in the box caused the product to no longer be sterile.
 
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Brand NamePERFIX PLUG
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 Key8019329
MDR Text Key125673908
Report Number1213643-2018-03801
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K922916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 10/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0112760
Device Lot NumberHUCU2915
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/10/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/05/2018
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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