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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 6" (16 CM) AGB+ CATHETER,INTRAVASCULAR,THERAPE

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ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 6" (16 CM) AGB+ CATHETER,INTRAVASCULAR,THERAPE Back to Search Results
Catalog Number ASK-42703-PRJ
Device Problem Unraveled Material (1664)
Patient Problem Insufficient Information (4580)
Event Date 09/21/2021
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4). The mdr report key is (b)(4). The mdr text key is (b)(4). The report number is mw5104274.
 
Event Description
Complaint found in maude database reports: "place a left internal jugular triple lumen when guidewire met resistance while attempting to withdraw. Guidewire began to unravel. Procedure aborted. ".
 
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Brand NameARROW PI CVC KIT: 3-L 7 FR X 6" (16 CM) AGB+
Type of DeviceCATHETER,INTRAVASCULAR,THERAPE
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.
ave. washington 3701
colonia panamericana, chihuahua
chihuahua 31200
MX 31200
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key12751463
MDR Text Key280112272
Report Number9680794-2021-00591
Device Sequence Number1
Product Code FOZ
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 Other
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberASK-42703-PRJ
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/08/2021
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

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