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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX / ARROW ARROW DUAL-LUMEN CENTRAL LINE; MULTI-LUMEN CENTRAL LINE
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TELEFLEX / ARROW ARROW DUAL-LUMEN CENTRAL LINE; MULTI-LUMEN CENTRAL LINE Back to Search Results
Model Number CDC-45802-XP1A
Device Problems Detachment Of Device Component (1104); Physical Resistance (2578)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/20/2018
Event Type  Injury  
Event Description
Pt had a dual lumen central line inserted in the operating room by anesthesia prior to surgery on (b)(6) 2018.On (b)(6) 2018 the rn attempted to d/c the central line per doctor's orders, but met resistance.Rn called anesthesiologist (same one that inserted the central line) to the bedside.Anesthesiologist pulled the central line without difficulty and realized the guide wire was still inserted.No harm to the patient.Care providers had no issues drawing blood, flushing, or administering medications through central line while guide wire inserted.Should there be a device that prevents utilization of the central line if the guide wire is still in place? it seems this would be an effective safety mechanism to insure the guide wire is removed.
 
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Brand Name
ARROW DUAL-LUMEN CENTRAL LINE
Type of Device
MULTI-LUMEN CENTRAL LINE
Manufacturer (Section D)
TELEFLEX / ARROW
MDR Report Key7384678
MDR Text Key104133322
Report NumberMW5076229
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier20800190211725
UDI-Public01208001902117254
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 03/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2019
Device Model NumberCDC-45802-XP1A
Device Lot Number23F17M0423
Was Device Available for Evaluation? Yes
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 Number1
Patient Outcome(s) Required Intervention;
Patient Age49 YR
Patient Weight154
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