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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS
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ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS Back to Search Results
Catalog Number CS-15703-E
Device Problem Complete Blockage (1094)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/25/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports the middle line gets blocked in use.The line was changed.
 
Event Description
The customer reports the middle line gets blocked in use.The line was changed.
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.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.
 
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Brand Name
ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
Type of Device
CATHETER PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8336421
MDR Text Key136061167
Report Number3006425876-2019-00131
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
PMA/PMN Number
K862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberCS-15703-E
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received03/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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