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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; KIT CATH CENT VENOUS 3 LUM 16CM
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TELEFLEX INCORPORATED ARROW; KIT CATH CENT VENOUS 3 LUM 16CM Back to Search Results
Model Number IPN036440
Device Problems Loose or Intermittent Connection (1371); Unraveled Material (1664)
Patient Problem Insufficient Information (4580)
Event Date 05/17/2021
Event Type  malfunction  
Event Description
The guidewire from the included aarow cvc kit completely unwound during deployment leading to loose wire attempting to enter the patient's bloodstream.Er doctor was able to remove and retrieve the wire but this could have been a catastrophic event.
 
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Brand Name
ARROW
Type of Device
KIT CATH CENT VENOUS 3 LUM 16CM
Manufacturer (Section D)
TELEFLEX INCORPORATED
2400 bernville rd
reading PA 19605 9607
Manufacturer (Section G)
TELEFLEX INCORPORATED
2400 bernville rd
reading PA 19605 9607
Manufacturer Contact
cheyenne stewart
3000 east sawyer road
republic, MO 65738
4176473205
MDR Report Key11852200
MDR Text Key260243811
Report Number3014527682-2021-00005
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier20801902117087
UDI-Public20801902117087
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN036440
Device Catalogue NumberCDC-42703-XP1A
Device Lot Number23F20D0107,23F20H0151,13F21A00
Was Device Available for Evaluation? No
Date Manufacturer Received05/17/2021
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 Initial
Patient Sequence Number1
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