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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" (2 CATHETER INTRAVASCULAR THERAP

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ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" (2 CATHETER INTRAVASCULAR THERAP Back to Search Results
Model Number IPN036438
Device Problem Material Separation (1562)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 04/20/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint is reported as: when the doctor was removing the wire, he noticed the wire had separated inside the patient. Xrays were taken, and revealed a small curvilinear metallic density overlying the right femoral head. It was reported there was no medical intervention and the piece of wire was not removed from the patient. There were no patient complications. No delay in treatment. At the time of this report the patient had been transferred to another facility for an unrelated issue.
 
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Brand NameARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" (2
Type of DeviceCATHETER INTRAVASCULAR THERAP
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 Key11803663
MDR Text Key250411619
Report Number9680794-2021-00208
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 company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN036438
Device Catalogue NumberCDC-45703-P1A
Device Lot Number13F20M0203
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/07/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/10/2021 Patient Sequence Number: 1
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