MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5; DURASEAL CRANIAL

Catalog Number 202050

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that the duraseal product would not seal.Additional information was requested but the customer would not provide any further information.

Manufacturer Narrative

Integra has completed their internal investigation on 03/01/2016.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: evaluation of device: one duraseal sealant system 5ml (qty 5) us was received opened by the account with the appropriate blister package in an undamaged condition.The visual inspection of the powder vial noted the product to be partially prepared.Further inspection noted that the powder vial cap had been completely recessed.The powder vial had blue residue indicating that the precursor solution had been fully injected and mixed.The blue precursor syringe was received engaged with the powder vial cap and had blue residue inside indicating that the mixed solution was drawn out of the powder vial.There was no evidence of polymer inside the syringes.The clear precursor was returned with approximately 2.5ml of liquid solution.A review of the device history record indicates this device lot number was released meeting all medtronic quality release specifications at the time of manufacture.A review of complaint data reveals no trend for a device related failure for this condition.The reported condition was confirmed.Root cause: the file was concluded to be a misuse by the end user.Replication of the observed conditions may occur if the syringe is not properly engaged with the powder vial cap or the solution is not mixed completely when preparing the product for application.

• Brand Name: DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5
• Type of Device: DURASEAL CRANIAL
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP; 311 enterprise drive; 311 enterprise drive; plainsboro NJ 08536
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORP; 311 enterprise drive; plainsboro NJ 08536
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5306252
• MDR Text Key: 34584751
• Report Number: 3003418325-2015-00022
• Device Sequence Number: 1
• Product Code: NQR
• Combination Product (y/n): N
• PMA/PMN Number: P040034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: 202050
• Device Lot Number: N5E0226X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1