MAUDE Adverse Event Report: ATRIUM MEDICAL CORP C-QUR V-PATCH; MESH, SURGICAL, POLYMERIC

Model Number 31200

Device Problem Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2016

Event Type  malfunction  

Manufacturer Narrative

Upon the completion of the investigation into this event a follow up report will be submitted.

Event Description

Received a report that when the package was opened, the clear sterile wrapper was caught in the seam of the foil wrapper.Device was not used.

Manufacturer Narrative

The complaint contends that the handling sleeve which the product sits in was caught in the seal.It is presumed to be the environmental seal that atrium places as the pouches come sealed on 3 sides from the vendor.Once the product is inserted in the pouch, a final environmental seal is placed at the top of the pouch.The complaint contends that the sleeve was caught in this seal.The hospital was concerned about the sterility of the product was in question so they discarded the part and packaging deciding not to use it.For this investigation, the packaging and product is not available to be analyzed.In reviewing the device history record (dhr) of the lot in question, the scrap collection work sheet lists 2 parts being scrapped for "incorrect placement of mesh in the pouch".This scrap description is usually reserved for when the handling sleeve appears to be in the sealing area of the environmental seal.The hospital complaint did detail that happening.The fact that manufacturing has rejects for this detailed on the dhr shows that they can inspect this out of the manufacturing process.However, without the actual product and packaging, engineering can't confirm this incident that the hospital in fact got a package with a handling sleeve stuck in the seal.Clinical evaluation: microorganisms can enter a surgical wound through various forms of contact, such as from the caregiver or surgical instrument and devices, or through microorganisms in the air.The instructions for use state that this device is supplied sterile and also states the method of sterilization.Infection is a risk associated with any type of surgery and should be considered as part of the education and informed consent decision that occurs between the patient and their physician prior to any surgery.The packaging must be inspected prior to use to ensure it is intact and not compromised in any way.

• Brand Name: C-QUR V-PATCH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORP; 40 continental blvd.; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORP; 40 continental blvd.; merrimack NH 03054
• Manufacturer Contact: theresa morin ; 40 continental blvd; merrimack, NH 03054 ; 6038645237
• MDR Report Key: 5885238
• MDR Text Key: 52385081
• Report Number: 3011175548-2016-00005
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00650862312003
• UDI-Public: 00650862312003
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090909
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/02/2019
• Device Model Number: 31200
• Device Catalogue Number: 31200
• Device Lot Number: 404916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2016
• 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