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

Catalog Number INSHITH

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 06/28/2023

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 facility reported that the hith kit (inshith) was damaged and there was a leak in the package.Additional information received indicates that the package was damaged in transit and based on the pictures provided, the item had oil on it.The customer was unable to use the item.No patient injury or surgical delay has been reported.

Manufacturer Narrative

The hith kit (inshith) was returned for evaluation: device history record (dhr) review - the dhr was reviewed, and no anomalies were found during the manufacturing and packaging process that could be related to the reported condition.Failure analysis - investigation was performed using photographs which were taken prior to receipt of the returned product, as the physical sample was not required to complete the evaluation.The photographs revealed the white box of a cranial access kit and the cardboard box the carrier supplied to be contaminated with some form of oil.The oil 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.The carrier supplied their house brand cardboard box to repackage the material, a style of box that is not used anywhere in our facility, and neither is there record of any oil spill affecting the product during the time of manufacture and shipping.Root cause - the product was damaged after leaving this site.The carrier damaged and repackaged the product instead of reporting the damage.No further investigation is required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

Event Description

N/a.

• 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: 17624215
• MDR Text Key: 321969227
• Report Number: 1722447-2023-00002
• 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: 04/26/2024

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: 7000262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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