MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION DURASEAL 5ML 5 KITS/BOX CE APPROVED; DURASEAL CRANIAL

Catalog Number DSD5005

Device Problem Chemical Problem (2893)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/30/2020

Event Type  malfunction  

Manufacturer Narrative

Duraseal (dsd5005) was not returned for evaluation; the root cause is undetermined and was unable to be confirmed in the complaint evaluation.A dhr review and trending were performed as part of the evaluation.Proper finished good testing was performed prior to release as indicated in the dhr.Product was not received for analysis and the investigation could not confirm the complaint.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.

Event Description

This is 2 of 2 reports linked to mfg report number 3003418325-2021-00004.A facility reported that two (2) vials of duraseal (dsd5005) were opened for an unspecified case and was to be in contact with a patient.The product in both vials was solid and did not dissolve once the blue liquid was added to it.There was no patient injury reported and delay in surgery is unknown.An additional two (2) packets of product were opened and used successfully.

• Brand Name: DURASEAL 5ML 5 KITS/BOX CE APPROVED
• Type of Device: DURASEAL CRANIAL
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; 105 morgan lane; plainsboro NJ 08536
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; plainsboro NJ 08536
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 11376352
• MDR Text Key: 265989873
• Report Number: 3003418325-2021-00005
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DSD5005
• Device Lot Number: 60212939
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2021
• Date Device Manufactured: 10/01/2019
• 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