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

Catalog Number 203001

Device Problem Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/29/2019

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

It was reported that the liquid in the tubes of the 203001 duraseal spine ous 3ml was very little and not enough to work with it.The date of the event was on (b)(6) 2019.The device was in contact with the patient.There was no patient injury.The event led to an increase in surgery time of about one (1) hour.There was no consequences for the patient due to the increase of surgery time.Another product was used to finish the procedure.Patient's age, gender, and type of surgery performed were not specified.

Manufacturer Narrative

The visual inspection of the returned product noted that the syringe inserted into the blue vial was empty, the other had 1 1/2 ml full of clear liquid.There was very little liquid in the blue vial.No powder was visible.Analysis concluded there were no assembly component related failures.The dhr review concluded there were no assembly component related failures at the time of release.The reported condition of very little liquid was confirmed.The investigation was unable to determine a root cause or establish a relationship between the devices and the reported incident.No enhancements or improvements were generated for the reported condition.

Event Description

N/a.

Manufacturer Narrative

Integra has performed a thorough review of the reported incident.There was no product received back, as such only a 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.Should new information become available, the file will be re-opened and the investigation will be amended as appropriate.

• 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: 8785678
• MDR Text Key: 150865369
• Report Number: 3003418325-2019-00023
• Device Sequence Number: 1
• Product Code: NQR
• Combination Product (y/n): N
• PMA/PMN Number: P080013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2019

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: Health Professional
• Device Catalogue Number: 203001
• Device Lot Number: N8HC891X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Initial Date Manufacturer Received: 06/28/2019
• Initial Date FDA Received: 07/12/2019
• Supplement Dates Manufacturer Received: 08/19/2019; 09/19/2019
• Supplement Dates FDA Received: 09/06/2019; 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1