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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL MAC CORDIS CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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TELEFLEX MEDICAL MAC CORDIS CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Device Problems Crack (1135); Material Twisted/Bent (2981)
Patient Problem Insufficient Information (4580)
Event Date 08/14/2021
Event Type  malfunction  
Event Description
Catheter dialator "bent" and slightly cracked when inserted into the sub-q tissue. Catheter withdrawn. This is for cvc insertions requiring more force to get over/around the clavicle. Fda safety report id # (b)(4).
 
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Brand NameMAC CORDIS CATHETER
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC 27560
MDR Report Key12353979
MDR Text Key267974744
Report NumberMW5103404
Device Sequence Number1
Product Code FOZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 08/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
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

Patient Treatment Data
Date Received: 08/20/2021 Patient Sequence Number: 1
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