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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 5-LUMEN 8.5FR X 16CM; CATHETER, INTRAVASCULAR, THERAPEUTIC
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ARROW INTERNATIONAL INC. ARROW CVC SET: 5-LUMEN 8.5FR X 16CM; CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
Model Number IPN030801
Device Problem Structural Problem (2506)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/12/2020
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).
 
Event Description
It was reported that the tissue dilatation cannula would not pass freely over the guide wire at skin level to deeper tissue.The guide wire was inserted into the right internal jugular vein.On closer inspection it was noted that there was a slight bur at the end of the cannula was noted.
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
 
Event Description
It was reported that the tissue dilatation cannula would not pass freely over the guide wire at skin level to deeper tissue.The guide wire was inserted into the right internal jugular vein.On closer inspection it was noted that there was a slight bur at the end of the cannula was noted.
 
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Brand Name
ARROW CVC SET: 5-LUMEN 8.5FR X 16CM
Type of Device
CATHETER, INTRAVASCULAR, THERAPEUTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9928507
MDR Text Key186731482
Report Number3006425876-2020-00316
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/23/2021
Device Model NumberIPN030801
Device Catalogue NumberCS-22855
Device Lot Number71F19K0186
Was Device Available for Evaluation? No
Date Manufacturer Received04/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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