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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT CATHETER INTRAVASCULAR THERAPE

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ARROW INTERNATIONAL INC. ARROW CVC KIT CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number VASCULAR UNKNOWN
Device Problem Fluid Leak (1250)
Patient Problem Insufficient Information (4580)
Event Date 02/08/2021
Event Type  malfunction  
Event Description
Complaint found in maude database: "the central line was leaking from the medial port. Reportedly, air was aspirated from it. ".
 
Manufacturer Narrative
(b)(4). The report number is mw5103075.
 
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Brand NameARROW CVC KIT
Type of DeviceCATHETER INTRAVASCULAR THERAPE
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key12593001
MDR Text Key281759511
Report Number9680794-2021-00513
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 other
Type of Report Initial,Followup,Followup
Report Date 09/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberVASCULAR UNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/29/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/07/2021 Patient Sequence Number: 1
Treatment
NOT REPORTED; NOT REPORTED; NOT REPORTED
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