MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP DURASEAL 5ML 1 KIT/BOX FOR JAPAN; DURASEAL CRANIAL

Catalog Number JDSD5001

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A physician reported that when the peg powder and blue liquid were mixed and transferred to the syringe, it was found that the amount was only 1.5 mm which was less than usual.Duraseal was changed to a new product to complete the procedure.There was no patient injury and delay in surgery was within 30 minutes with no adverse consequences to the patient.No further information was provided by the facility.

Manufacturer Narrative

Duraseal (jdsd5001) was not returned for evaluation (the product sent back thru fedex was not received by a known employee at the integra site in charge of sample receipts, fedex was contacted to raise this issue and to try to get further info and none was available); therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer 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.

• Brand Name: DURASEAL 5ML 1 KIT/BOX FOR JAPAN
• Type of Device: DURASEAL CRANIAL
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP; 1000 campus drive; 1000 campus drive; princeton NJ 08536
• MDR Report Key: 10953056
• MDR Text Key: 232560255
• Report Number: 3003418325-2020-00022
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: JDSD5001
• Device Lot Number: 60215507
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1