MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. MODIFIED KUGEL PATCH; SURGICAL MESH

Catalog Number 0115816

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 08/28/2019

Event Type  malfunction  

Manufacturer Narrative

Visual evaluation of the sample as received confirms the product was correctly sealed at the chevron end where the pouch has been opened.This is indicated by the presence of clean transfer of the seal when the product was opened.At the opening there are no anomalies in the pouch materials or seal found.The remainder of the supplier seal on both sides of pouch remains sealed and is in good condition.The bottom manufacturing seal is also sealed and in good condition.The pouch was then completely opened to show a complete seal transfer to match that of the top chevron seal finding no anomalies in the seal or pouch materials.Based on the product evaluation the received product pouch was correctly sealed prior to being opened.As received the package was opened, as such it cannot be determined why the user felt they could open the package without resistance.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date this is the only reported complaint for this production lot of (b)(4) units released for distribution in april, 2018.

Event Description

As reported on (b)(6) 2019 the bard modified kugel was pulled from hospital inventory and, "when the circulating nurse attempted to open the sterile package, they could open the package without resistance.They alleged that the package was originally opened.The device was not used." as reported, there was no abnormality reported with the outer product packaging.

• Brand Name: MODIFIED KUGEL PATCH
• 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: 9115329
• MDR Text Key: 159949625
• Report Number: 1213643-2019-09259
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741030826
• UDI-Public: (01)00801741030826
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K963141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 0115816
• Device Lot Number: HUCQ0917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2018
• 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