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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 30 CM CATHETER INTRAVASCULAR THERAPE

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ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 30 CM CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number CS-24703-E
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/06/2022
Event Type  malfunction  
Event Description
It was reported "the junction between needle and syringe was loose". No patient harm. The device was replaced. The patient's condition is reported as fine.
 
Manufacturer Narrative
(b)(4).
 
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Brand NameARROW CVC SET: 3-LUMEN 7 FR X 30 CM
Type of DeviceCATHETER INTRAVASCULAR THERAPE
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 Key13388668
MDR Text Key285162894
Report Number3006425876-2022-00072
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeTW
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 01/06/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberCS-24703-E
Device Lot Number71F21A2046
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received02/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/28/2021
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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