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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MIDLINE CATHETERIZATION KIT CATHETER, INTRAVASCULAR, THERAPEUTIC

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ARROW INTERNATIONAL LLC ARROW MIDLINE CATHETERIZATION KIT CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
Model Number IPN921190
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/08/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that 8-9 days after insertion, a leak of infused solution occurs between the catheter and the connection. No patient harm reported. The device was removed and replaced with a different brand catheter. The patient's condition is reported as fine.
 
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Brand NameARROW MIDLINE CATHETERIZATION KIT
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
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 Key15140556
MDR Text Key303340924
Report Number3006425876-2022-00673
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/12/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN921190
Device Catalogue NumberEU-02041-ML
Device Lot Number71F22B0346
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/16/2022
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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