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

Catalog Number 0112950

Device Problems Sticking (1597); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2017

Event Type  malfunction  

Manufacturer Narrative

As reported the expired device was implanted in error.A review of our records shows that the device was well within the date of expiry (04/28/2017) when provided to the facility in 2012.This event is confirmed for use related.The ifu instructs the user to inspect the package prior to use.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.Remains implanted.

Event Description

It was reported that on (b)(4) 2017 an expired bard perfix plug was placed in a patient in error.As reported the surgeon elected to leave the device implanted and there was no medical or surgical intervention performed.It is reported that there was no adverse outcome and per the surgeon "the patient is doing well and is pleased with his outcome.".

• Brand Name: PERFIX PLUG
• Type of Device: SURGICAL 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 Key: 6971042
• MDR Text Key: 90772062
• Report Number: 1213643-2017-00719
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016653
• UDI-Public: (01)00801741016653(17)170428(10)HUWD1431
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K922916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2017
• Device Catalogue Number: 0112950
• Device Lot Number: HUWD1431
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/02/2017
• Initial Date FDA Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 35 YR