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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC / TELEFLEX, INC TELEFLEX TRIPLE LUMEN CATHETER CENTRAL LINE CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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ARROW INTERNATIONAL LLC / TELEFLEX, INC TELEFLEX TRIPLE LUMEN CATHETER CENTRAL LINE CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problems Cardiac Arrest (1762); Death (1802)
Event Date 05/22/2020
Event Type  Death  
Event Description
Pt was two days post cabg when he suffered a cardiac arrest after a blood transfusion. During cpr, it was noted that his triple lumen catheter had become un-attached and one of the pots was broken away from the hub - leaving the port open to air. During investigation, it was noted that the plastic "tail" broke loose from the blue plastic hub (connection). There did not appear to be a cut or tear in the actual tubing, it appeared to have separated at the point of attachment where it is glued into the hub. Fda safety report id# (b)(4).
 
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Brand NameTELEFLEX TRIPLE LUMEN CATHETER CENTRAL LINE
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
ARROW INTERNATIONAL LLC / TELEFLEX, INC
morrisville NC 27560
MDR Report Key10520607
MDR Text Key206757773
Report NumberMW5096534
Device Sequence Number1
Product Code FOZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 09/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2020
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
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? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 09/10/2020 Patient Sequence Number: 1
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