MAUDE Adverse Event Report: INTEGRA - PRINCETON DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5; DURASEAL CRANIAL

Catalog Number 202050

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that the duraseal dural sealant system 5ml us box of 5 (202050) was wet because the plastic film had tears and that it was a packaging defect.There was no patient involvement.

Manufacturer Narrative

A photo of the duraseal dural sealant system (202050) was provided for evaluation, as no sample was available during the time of investigation: device history record (dhr) - the dhr was reviewed for the material involved, no issues related to the failure mode reported in this complaint were noticed during normal production; material was built using validated parameters.Failure analysis - photos were provided by the customer in which it is evidenced that the plastic film of the outside package is slightly torn, causing the corner to appear wet.Current procedures in place ensure the duraseal finished good was properly packaged and shipped and confirmed per the dhr review.Any potential issues prior to the product¿s hand-off to the shipping vendor, are minimized by following the proper standard operating procedures that have been established at the manufacturing site and distribution center.This shipment arrived at the customer after the validated time frame as product shipped from the distribution center on 6/23/2023 and it arrived at the customer on 8/2/2023 according to the tracking number.As such, the issue identified is most likely attributed to the extended transit as the product was delivered by fedex 6 weeks after pick up, even with integra requesting overnight shipping.Root cause - the photo evidence confirms the failure mode reported, and the root cause is determined to be an excursion in shipping time.Per the dfmea, potential causes of failure include: issues with packaging integrity.No further investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

Event Description

N/a.

• Brand Name: DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5
• Type of Device: DURASEAL CRANIAL
• 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: 17619477
• MDR Text Key: 321947888
• Report Number: 3003418325-2023-00013
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2023

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: 202050
• Device Lot Number: 60466710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2023
• Supplement Dates Manufacturer Received: 09/25/2023
• Supplement Dates FDA Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2023
• 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