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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 PERFIX PLUG; SURGICAL MESH
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DAVOL INC., SUB. C.R. BARD, INC. -1213643 PERFIX PLUG; SURGICAL MESH Back to Search Results
Catalog Number 0112770
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/23/2022
Event Type  malfunction  
Event Description
As reported on (b)(6) 2022 prior to use, it was noted the perfix plug onlay mesh was within the sterile seal of the packaging with the presence of a micro-hole at the weld, allegedly creating a non-sterile condition.Another perfix plug was used to complete the procedure.There was no reported patient injury.
 
Manufacturer Narrative
Based on the information provided, no conclusion can be made at this time.As reported, the sample is being returned for evaluation.If/when the sample is received, and the evaluation has been completed a emdr will be submitted to document the results.The instructions-for-use, provided with the device states, ¿this device must be sterile before use.Please inspect the packaging to be sure it is intact and undamaged.¿ not returned.
 
Event Description
As reported on (b)(6) 2022 prior to use, it was noted the perfix plug onlay mesh was within the sterile seal of the packaging with the presence of a micro-hole at the weld, allegedly creating a non-sterile condition.Another perfix plug was used to complete the procedure.There was no reported patient injury.
 
Manufacturer Narrative
Based on the information provided, no conclusion can be made at this time.As reported, the sample is being returned for evaluation.If/when the sample is received, and the evaluation has been completed a semdr will be submitted to document the results.The instructions-for-use, provided with the device states, ¿this device must be sterile before use.Please inspect the packaging to be sure it is intact and undamaged.¿.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the results of the sample evaluation.The subject device was returned for evaluation.As received, the onlay is positioned near the sterile seal within the blister tray and is not stuck or within the seal or on the tyvek.There are no visible holes in the tyvek lid and the plug is in good condition.There are no marks or visible evidence on the tyvek or within the seal transfer that would suggest the mesh was inadvertently within the seal during the packaging / sealing process.No manufacturing anomalies are found.Based on the sample condition the sterile barrier was intact when the blister tray was opened unconfirmed, a non-sterile condition.Review of manufacturing records confirms 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 february 2022.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 : sample evaluated.
 
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Brand Name
PERFIX PLUG
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 Key16036320
MDR Text Key306188247
Report Number1213643-2022-00816
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00801741016615
UDI-Public(01)00801741016615
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K922916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 01/02/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0112770
Device Lot NumberHUFZ1083
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/23/2022
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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