MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP DURASEAL SPINE OUS 3ML KIT 1KIT/BOX CE APPROVED

Catalog Number 203001

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A distributor reported on behalf of the customer that 203001 duraseal spine ous 3ml kit 1kit was opened and when the dilutent syringue was connected to the powder vial to mix the two and turned around to draw the mixture back into the syringue to use as directed, the dilutent/powder mixture leaked out of the vial and only minimal was left in the vial which was not enough to use.The date of the incident was on (b)(6) 2018.There was no patient injury reported.The event led to an increase of surgery time of about 3 hours.Additional information was received on 13feb2019 indicating that the (b)(6) year old male patient was under anesthesia when the dysfunction was observed.The hospital had to source for another duraseal as the remainder of the item was packed for another surgeon case.Patient outcome was reported as doing well.

Manufacturer Narrative

Integra has performed a thorough review of the reported incident.There was no product received back, as such only a device history record (dhr) review was conducted.The dhr review concluded there were no assembly component related failures at the time of release.With the information provided, a root cause could not be reliably determined.

Manufacturer Narrative

Product was received for evaluation and had the bioset cap pressed down with the red mark showing in the vial (this is not how it is indicated in the instructions for use, the red mark should not be showing for the solution not to spill going in or out of the peg vial).The grommet was perforated by the bioset spike.There were traces of blue solution observed inside the vial.There was blue solution on the outside of the bioset, the solution was also spilled between the spike and the rubber grommet, indicating that the product had leaked.All 3 spray tips were received back along with the y-connector, they showed no traces of blue peg.The dhr review and product analysis of the polymer kit concluded there were no assembly component related failures with the returned product or at the time of release.The investigation was able to determine a root cause as the bioset on the vial not activated according to ifu.If the red indicating line on the bioset is still showing, the solution will spill going into the vial to reconstitute, or when drawing back the reconstituted solution.The reported condition was confirmed.The file will be closed as user error.

• Brand Name: DURASEAL SPINE OUS 3ML KIT 1KIT/BOX CE APPROVED
• Type of Device: DURASEAL SPINE
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP; 311 enterprise drive; 311 enterprise drive; plainsboro NJ 08536
• MDR Report Key: 8345642
• MDR Text Key: 139876204
• Report Number: 3003418325-2019-00001
• 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: distributor,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 203001
• Device Lot Number: 60137689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2019
• Date Manufacturer Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1