MAUDE Adverse Event Report: INTEGRA PAIN MANAGEMENT HITH KIT; N/A

Catalog Number INSHITH

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 07/06/2023

Event Type  malfunction  

Event Description

A facility reported that they received a case of the hith kit (inshith) with water damage.There was no patient injury or surgical delay.

Manufacturer Narrative

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

Manufacturer Narrative

The hith kit (inshith) was returned for evaluation: device history record (dhr) - a dhr review was performed, and no related issue was found.Failure analysis - upon investigation, photographs were taken of the returned product for further analysis.The white box of a cranial access kit was contaminated with water.The water has not penetrated through the foam into the sterile pouch inside the white cardboard box, but it is an unacceptable cosmetic defect that would erode the customer's confidence in the cleanliness and safety of the product.Excessive water contamination could absolutely breach the sterile barrier and introduce bacteria.The failure was caused by the shipping process providing inadequate protection from severe storms.Root cause - the product was damaged by the carrier after leaving this site.Dhrs were reviewed and warehouse inspected to confirm no potential source of water contamination was present or identifiable as having been a past source of water contamination.There was no adverse trend identified while conducting the investigation and trend analysis.Therefore, no corrective action is required at this time.

• Brand Name: HITH KIT
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA PAIN MANAGEMENT; 3395 west 1820 south; 3395 west 1820 south; salt lake city UT
• Manufacturer (Section G): INTEGRA PAIN MANAGEMENT; 3395 west 1820 south; salt lake city UT
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17624216
• MDR Text Key: 322365801
• Report Number: 1722447-2023-00003
• Device Sequence Number: 1
• Product Code: HBG
• Combination Product (y/n): N
• PMA/PMN Number: K961113
• 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: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: INSHITH
• Device Lot Number: 7028225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1