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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTI-LUMEN/PSI SET CATHETER,INTRAVASCULAR,THERAP

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ARROW INTERNATIONAL LLC ARROW MULTI-LUMEN/PSI SET CATHETER,INTRAVASCULAR,THERAP Back to Search Results
Catalog Number SI-11142
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/16/2022
Event Type  malfunction  
Manufacturer Narrative
Qn#(b)(4).
 
Event Description
It was reported "blood leak at the entrance of the psi part". The product was used with an edwards swan catheter. The swan catheter was removed and the leak stopped. No patient harm reported. The patient's condition is reported as fine.
 
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Brand NameARROW MULTI-LUMEN/PSI SET
Type of DeviceCATHETER,INTRAVASCULAR,THERAP
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
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 Key14978703
MDR Text Key304022165
Report Number9680794-2022-00424
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K002507
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/23/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberSI-11142
Device Lot Number14F22B0196
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/03/2022
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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