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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTERNATIONAL LLC (SUBSIDIARY OF TELEFLEX INCORPORATED) MAC TWO LUMEN CENTRAL VENOUS ACCESS KIT CATH GARD INTRODUCER, CATHETER

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INTERNATIONAL LLC (SUBSIDIARY OF TELEFLEX INCORPORATED) MAC TWO LUMEN CENTRAL VENOUS ACCESS KIT CATH GARD INTRODUCER, CATHETER Back to Search Results
Lot Number CDC-11242-1A
Device Problems Suction Problem (2170); Defective Device (2588)
Patient Problem Insufficient Information (4580)
Event Date 11/23/2021
Event Type  malfunction  
Event Description
Central line placed in surgery, when staff went to draw inability to aspirate, line changed out and it was noted that the initial line did not have a hole in the side- defective two lumen central venous catheter. Fda safety report id # (b)(4).
 
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Brand NameMAC TWO LUMEN CENTRAL VENOUS ACCESS KIT CATH GARD
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
INTERNATIONAL LLC (SUBSIDIARY OF TELEFLEX INCORPORATED)
MDR Report Key12883092
MDR Text Key281507637
Report NumberMW5105619
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberCDC-11242-1A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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