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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW ARTERIAL CATH SET: 20GA X 5CM; CATHETER, PERCUTANEOUS
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ARROW INTERNATIONAL INC. ARROW ARTERIAL CATH SET: 20GA X 5CM; CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number SAC-00520
Device Problems Obstruction of Flow (2423); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/19/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that after 24-48 hours, the catheter must be substituted because it kinks and it is not possible detect pressure values or make blood samples.It's reported that no medical intervention was required.
 
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.
 
Event Description
It was reported that after 24-48 hours, the catheter must be substituted because it kinks and it is not possible detect pressure values or make blood samples.It's reported that no medical intervention was required.
 
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Brand Name
ARROW ARTERIAL CATH SET: 20GA X 5CM
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8148174
MDR Text Key129891575
Report Number3006425876-2018-00782
Device Sequence Number1
Product Code DQY
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 11/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/19/2023
Device Catalogue NumberSAC-00520
Device Lot Number71F18J1377
Was Device Available for Evaluation? No
Date Manufacturer Received01/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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