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

Catalog Number 203001

Device Problems Chemical Problem (2893); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2022

Event Type  malfunction  

Event Description

This is 2 of 2 reports linked to mfg report number 3003418325-2022-00003: a facility reported that when pressing both syringe plungers in the duraseal spine ous 3ml kit 1kit/box (203001) they were stuck and the liquids were not going out.The customer thinks there is something wrong with the y-connector as only clear solution went out.The device was in contact with a patient and led to increased surgery time of 30 minutes.There was no patient injury.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

Duraseal was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history records (dhr) was reviewed and no anomalies were found.The root cause(s) of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Manufacturer Narrative

Duraseal was not returned for evaluation; therefore, an evaluation of the device could not be performed; however, a video was provided by the facility.From the video, it is clear that the assembly was not performed according to ifu.Root cause is likely due to not following ifu instructions for assembly of the component to function properly to ensure the gel formation and delivery.Lot number information has been provided; therefore, device history records (dhr) was reviewed and no anomalies were found.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.Without the sample returned, we are not capable of determining the root cause.No corrective action is recommended at this time, as this complaint issue does not represent an adverse trend, unacceptable individual risk, or significant non-conformance to regulatory requirements.

• Brand Name: DURASEAL SPINE OUS 3ML KIT 1KIT/BOX CE APPROVED
• Type of Device: DURASEAL SPINE
• Manufacturer (Section D): INTEGRA - PRINCETON; 1100 campus road; 1100 campus road; princeton NJ
• Manufacturer (Section G): INTEGRA - PRINCETON; 1100 campus road; none; princeton NJ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 13720401
• MDR Text Key: 288684273
• Report Number: 3003418325-2022-00004
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• 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: 60309566
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2022
• Date Device Manufactured: 08/01/2021
• 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