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

Catalog Number 0112960

Device Problems Use of Device Problem (1670); Expiration Date Error (2528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2019

Event Type  malfunction  

Manufacturer Narrative

This event is confirmed as a use related error.Our records show the device was provided to the facility on 05/14/2014, almost five years prior to the expiration date of 04/28/2019.The expiration date is located on multiple layers of the packaging.Implanted.

Event Description

It was reported that the patient underwent a laparoscopic hernia repair on (b)(6) 2019 and was implanted with a bard/davol perfix plug.As reported, the surgeon discovered the mesh was expired after the device was implanted, and the patient was still on the operating table for the procedure during discovery.The customer reports that the surgeon chose to leave the mesh implanted "and proceed to close the patient" and did not take any additional medical action or provide extra antibiotics to the patient.During the patients postoperative appointment, the surgeon disclosed to the patient that an expired mesh was implanted and "the patient was okay with this." the customer reports that the patient did not have any post operative complications, is healing well from the procedure and the device remains implanted in the patient.

• 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: 8717971
• MDR Text Key: 148916874
• Report Number: 1213643-2019-05269
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016660
• UDI-Public: (01)00801741016660
• 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: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2019
• Device Catalogue Number: 0112960
• Device Lot Number: HUYD0149
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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