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

Catalog Number 0117080

Device Problems Unsealed Device Packaging (1444); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The samples are expected to be returned for evaluation, however have not been received to date.A review of the manufacturing records was performed and found that the lot ((b)(4) units) was manufactured to specification, with no anomalies noted.No other complaints have been reported to date for this lot.When the samples are returned a supplemental mdr will be sent to document our findings.This report documents one of the two perfix light plugs, 1213643-2016-00569 documents the other unit.

Event Description

It was reported to bard/davol by our (b)(4) affiliate that during their incoming inspection two perfix light plugs were identified as having a possible insufficient seal.The units are being returned for evaluation.As a possible breach of sterile barrier condition was alleged to be present an mdr is being filed to document the condition reported.

• Brand Name: PERFIX LIGHT 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 berg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 6173788
• MDR Text Key: 62354328
• Report Number: 1213643-2016-00577
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K092032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2016

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: No Information
• Device Expiration Date: 06/28/2021
• Device Catalogue Number: 0117080
• Device Lot Number: HUAT2532
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/15/2016
• Initial Date FDA Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1