MAUDE Adverse Event Report: AVID MEDICAL INC., A MEDICAL ACTION IND COMPANY 305 HEAD & NECK CUSTOM PACK; NEUROLOGICAL TRAY

Model Number HEAD & NECK CUSTOM PACK

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2019

Event Type  malfunction  

Event Description

Scrub tech upon opening the custom pack to prepare for the case observe large amounts of particulates in the sterile basin that was inside the pack.(b)(6) operating room #2 on (b)(6) 2019 about 0720 hrs.No staff or pt injured, this pack was destroyed and supplies pulled from stock to make up the sterile setup.(b)(4) submitted.Fda report filed.Certified scrub tech opened the pack, product sterile and packed in manufactured packaging expire on 11/01/2020, lot #1358662.Product should be free of foreign debris.Incident of this nature is not uncommon and is continued to be reported as they occur.Vendor poc for the (b)(6) notified.(b)(6).(b)(4).

• Brand Name: HEAD & NECK CUSTOM PACK
• Type of Device: NEUROLOGICAL TRAY
• Manufacturer (Section D): AVID MEDICAL INC., A MEDICAL ACTION IND COMPANY 305
• MDR Report Key: 9192353
• MDR Text Key: 162468761
• Report Number: MW5090366
• Device Sequence Number: 1
• Product Code: OJG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2020
• Device Model Number: HEAD & NECK CUSTOM PACK
• Device Catalogue Number: WLF009-18
• Device Lot Number: 1358662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1