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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW LBCVC KIT: 3-L 12 FR X 20 CM ANTIMICROBI CATHETER, INTRAVASCULAR, THERAPEUTIC

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ARROW INTERNATIONAL INC. ARROW LBCVC KIT: 3-L 12 FR X 20 CM ANTIMICROBI CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
Catalog Number CDC-25123-X1A
Device Problems Kinked (1339); Device Damaged Prior to Use (2284); Cut In Material (2454)
Patient Problem No Patient Involvement (2645)
Event Date 05/07/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports: the spring wire guide within the (b)(4) kit was noticed to be bent and partially cut prior to use on a patient.
 
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Brand NameARROW LBCVC KIT: 3-L 12 FR X 20 CM ANTIMICROBI
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 Key7536949
MDR Text Key109029370
Report Number1036844-2018-00153
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2019
Device Catalogue NumberCDC-25123-X1A
Device Lot Number23F17K0197
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/09/2017
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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