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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7FR X 20CM CATHETER,INTRAVASCULAR,THERAP

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ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7FR X 20CM CATHETER,INTRAVASCULAR,THERAP Back to Search Results
Catalog Number CV-26702-E
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/23/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
"patient with mixed respiratory failure requiring central vascular access, it was not possible to insert a peripherally inserted central catheter, so the right subclavian bilumen catheter was inserted, which presented damage to the guidewire when inserting the appropriate vein (it was fracture in multiple sites), which generates inability to dilate (dilator deformity) without allowing advancement of the central catheter, thus requiring the opening of a second bilumen catheter. " there was no patient injury or complication.
 
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Brand NameARROW CVC SET: 2-LUMEN 7FR X 20CM
Type of DeviceCATHETER,INTRAVASCULAR,THERAP
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ 591 01
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key12729565
MDR Text Key279346899
Report Number3006425876-2021-01014
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K900263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCV-26702-E
Device Lot Number71F21D2221
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/29/2021
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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