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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. PRIMARY ADULT INTUBATION KIT

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MEDLINE INDUSTRIES INC. PRIMARY ADULT INTUBATION KIT Back to Search Results
Catalog Number DYNJAA247
Device Problem Material Twisted/Bent (2981)
Patient Problems Cardiopulmonary Arrest (1765); Hypoventilation (1916); Hypoxia (1918); No Known Impact Or Consequence To Patient (2692)
Event Date 02/20/2020
Event Type  Injury  
Manufacturer Narrative
It was reported that a patient was undergoing an unspecified procedure and the endotracheal tube (ett) was noted to be twisted inside of the patient resulting in the inability to ventilate the patient. The facility reported that the incident occurred during the procedure and the patient had to be intubated again. No additional information is available at this time. There was no further intervention reported related to the incident. Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer. The sample has not been returned for evaluation. Due to the reported incident and in an abundance of caution, this medwatch is being filed. If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
 
Event Description
It was reported that a patient was undergoing an unspecified procedure and the endotracheal tube (ett) was noted to be twisted inside of the patient resulting in the inability to ventilate the patient.
 
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Type of DevicePRIMARY ADULT INTUBATION KIT
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
three lakes drive
northfield, il
Manufacturer Contact
teresa maynard
three lakes drive
northfield, il 
9311514
MDR Report Key9857665
MDR Text Key190751535
Report Number1417592-2020-00030
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberDYNJAA247
Device Lot Number19182386
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/19/2020 Patient Sequence Number: 1
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