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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW AM/AT PI MIDLINE 2-L: 5.5FR X 15CM CATHETER, INTRAVASCULAR, THERAPEUTIC

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ARROW INTERNATIONAL INC. ARROW AM/AT PI MIDLINE 2-L: 5.5FR X 15CM CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
Catalog Number CDC-41552-MPK1A
Device Problems Fracture (1260); Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/20/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports: the line was placed on (b)(6) 2020, vascular nurse got a call about a midline that was leaking. When the nurse arrived in the patient's room, the nurse found the pigtail had fractured and was laying on the bedside table next to the patient. The patient is fine with no injury. The line was removed and replaced with another device.
 
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Brand NameARROW AM/AT PI MIDLINE 2-L: 5.5FR X 15CM
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
312 commerce place
asheboro NC 27203
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key9930287
MDR Text Key186604013
Report Number1036844-2020-00130
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCDC-41552-MPK1A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/06/2020
Was Device Evaluated by Manufacturer? Yes
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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