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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN/PSI SET CATHETER,INTRAVASCULAR,THERAP Back to Search Results
Catalog Number SI-11142
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/01/2019
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).
 
Event Description
The customer initially reports that the md found the needle defective. Additional information indicates that the user tried to connect the syringe and the needle, but the needle was too loose to connect.
 
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Brand NameARROW MULTI-LUMEN/PSI SET
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
9194334854
MDR Report Key9817558
MDR Text Key182935840
Report Number3006425876-2020-00255
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K002507
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2022
Device Catalogue NumberSI-11142
Device Lot Number71F18C0280
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/17/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/21/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/31/2022
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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