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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.
 
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.
 
Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
 
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Brand Name
ARROW MULTI-LUMEN/PSI SET
Type of Device
CATHETER,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 Other
Type of Report Initial,Followup
Report Date 06/23/2022
1 Device was Involved in the Event
1 Patient was 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
Patient Sequence Number1
Treatment
EDWARDS SWAN CATHETER - PRODUCT 777F8, LOT 6378329; EDWARDS SWAN CATHETER - PRODUCT 777F8, LOT 6378329
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