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U.S. Department of Health and Human Services

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

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AVID MEDICAL INC., A MEDICAL ACTION IND COMPANY 305 HEAD & NECK CUSTOM PACK NEUROLOGICAL TRAY Back to Search Results
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).

 
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Brand NameHEAD & NECK CUSTOM PACK
Type of DeviceNEUROLOGICAL TRAY
Manufacturer (Section D)
AVID MEDICAL INC., A MEDICAL ACTION IND COMPANY 305
MDR Report Key9192353
MDR Text Key162468761
Report NumberMW5090366
Device Sequence Number1
Product Code OJG
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
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
0 PatientS WERE Involved in the Event:
Date FDA Received10/11/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/01/2020
Device MODEL NumberHEAD & NECK CUSTOM PACK
Device Catalogue NumberWLF009-18
Device LOT Number1358662
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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