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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CG+ PICC/DELTA FG: 2-L 5.5 FR X 50 CM INTRODUCER, CATHETER

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ARROW INTERNATIONAL INC. ARROW CG+ PICC/DELTA FG: 2-L 5.5 FR X 50 CM INTRODUCER, CATHETER Back to Search Results
Catalog Number CDC-45052-VPS2
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nausea (1970); Tachycardia (2095); Reaction (2414)
Event Date 10/27/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Complaint verification testing could not be performed as no sample was returned for analysis. The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer. 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.
 
Event Description
The customer reports that a single lumen antimicrobial device was used on a patient. Allergic reaction occurred. The device was pulled right away and called rrt. Nausea, vomit, puritis and tachycardia was reported.
 
Manufacturer Narrative
(b)(4). It is not documented if the patient has any reported allergies.
 
Event Description
The customer reports that a single lumen antimicrobial device was used on a patient. Allergic reaction occurred. The device was pulled right away and called rrt. Nausea, vomit, puritis and tachycardia was reported.
 
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Brand NameARROW CG+ PICC/DELTA FG: 2-L 5.5 FR X 50 CM
Type of DeviceINTRODUCER, CATHETER
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 Key7024503
MDR Text Key248754028
Report Number1036844-2017-00391
Device Sequence Number1
Product Code DYB
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 10/30/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCDC-45052-VPS2
Device Lot NumberUNKNOWN
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 Received12/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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