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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. ARROW MIDLINE CATHETERIZATION KIT CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
Model Number IPN036127
Device Problems Entrapment of Device (1212); Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/24/2020
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4). Additional customer information: the needle and guide were removed together. The whole system was blocked. It was impossible to insert a new needle. Bleeding. No medical intervention was required.
 
Event Description
It was reported that the swg (spring wire guide) was stuck in the patient so the needle had to be entirely removed. Three different staff members tried to remove the guide, but they all found it impossible to remove.
 
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Brand NameARROW MIDLINE CATHETERIZATION KIT
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC
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 Key9693551
MDR Text Key180325666
Report Number3006425876-2020-00135
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/17/2021
Device Model NumberIPN036127
Device Catalogue NumberEU-02041-ML
Device Lot Number71F19L2322
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/27/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/13/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/28/2019
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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