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

Catalog Number 0112760

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The sample evaluation confirms the reported condition of breach of sterility. A slice was found to be present in the outer carton and when the outer carton was opened the slice was found to have gone through the lid of the tyvek tray which contained the perfix plug device, confirming a breach of sterility. No manufacuturing anomalies were found. The slice was likely caused by a sharp object, i. E. Box cutter or other type of blade, used during the removal from a shipper box that penetrated through the packaging. When the damage occurred cannot be determined. To date this is the only reported complaint for this production lot of (b)(4) units released for distribution in september, 2018. A review of the manufacturing records was performed and found that the lot was manufactured to specification. There was no patient involvement.

Event Description

As reported per customer contact: the perfix plug was received by the materials manager who opened the shipping package (by hand) and noted the inner product box to have a slit in it. Contact reports the slit in the box caused the product to no longer be sterile.

• 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: 8019329
• MDR Text Key: 125673908
• Report Number: 1213643-2018-03801
• Device Sequence Number: 1
• Product Code: FTL
• 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

• Type of Report: Initial
• Report Date: 10/30/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 0112760
• Device Lot Number: HUCU2915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial