MAUDE Adverse Event Report: INTEGRA LIFE SCIENCES CORP 5ML DURASEAL SINGLE KIT PER BOX US; DURASEAL CRANIAL

Catalog Number 202010DS

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2020

Event Type  malfunction  

Manufacturer Narrative

The device is not expected to be 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 customer reported that an (b)(6) year old male patient underwent a severe trauma cranioencephalic procedure on (b)(6) 2020.When the surgeon and assistant opened the 202010ds 5ml duraseal single kit per box, they found that the quantity sealant of the syringe only had half.The product was in contact with the patient with no patient injury.There was a delay in surgery with no specific time given.The procedure was not delayed, the device was requested intraoperatively.No medical revision or intervention needed.

Manufacturer Narrative

Integra has performed a thorough review of the reported incident.There was no product received back, as such only a dhr review could be performed.At the time of manufacturing, records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications.With the information provided a root cause could not be reliably determined.There currently is a corrective action plan open at the manufacturing vendor site, to address syringes being half filled.Different activities have been implemented in the production floor to mitigate this failure mode reported.Post market vigilance will continue to monitor this condition for future potential action.Should new information become available, the file will be re-opened and the investigation will be amended as appropriate.

Event Description

N/a.

• Brand Name: 5ML DURASEAL SINGLE KIT PER BOX US
• Type of Device: DURASEAL CRANIAL
• Manufacturer (Section D): INTEGRA LIFE SCIENCES CORP; 1100 campus drive; 1100 campus drive; princeton NJ 08536
• MDR Report Key: 10486246
• MDR Text Key: 206823098
• Report Number: 3003418325-2020-00013
• 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
• Type of Report: Initial,Followup
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 202010DS
• Device Lot Number: 60207924
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 18 YR