MAUDE Adverse Event Report: INTEGRA PAIN MANAGEMENT UNKNOWN CRANIAL ACCESS KIT

Catalog Number XXX-CRANIAL ACCESS KIT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

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 cranial access kit (inshith) was used on a patient, and mrsa was confirmed in ventric track infection.Cerebrospinal fluid (csf) was negative, but the catheter tip tested positive.The facility has indicated that risk management is investigating this event and they will submit a report if it is determined that this event is related to the access kit in question.Additional information was later received from the facility indicating the following: "we responded to the recall and concluded our investigation.We did not feel this incident met the criteria of an adverse device related report." no information on catalog# or lot# has been provided despite our attempts.

Event Description

N/a.

Manufacturer Narrative

Additional information: please note that this complaint is related to a recall ((b)(4)).

• Brand Name: UNKNOWN CRANIAL ACCESS KIT
• Type of Device: CRANIAL ACCESS KIT
• 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: 18731370
• MDR Text Key: 335704601
• Report Number: 1722447-2024-00003
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-CRANIAL ACCESS KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• 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