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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 8 FR X 20 CM CATHETER,INTRAVASCULAR,THERAP

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ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 8 FR X 20 CM CATHETER,INTRAVASCULAR,THERAP Back to Search Results
Catalog Number CS-25802-E
Device Problem Insufficient Information (3190)
Patient Problems Reaction (2414); Bronchospasm (2598)
Event Date 12/04/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
"during surgery on (b)(6), the patient had bronchospasm shock once the cvc was inserted. Because the acute allergic reaction happened during surgery, the delayed allergic reactions caused by other medication can be ruled out. Therefore, it was suspected that both fentanyl and chlorhexidine of the cvc coating could be the cause of acute bronchospasm shock. Because the patient continued injecting fentanyl on (b)(6) , it was speculated that the coating chlorhexidine of cvc was more likely to be the cause".
 
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Brand NameARROW CVC SET: 2-LUMEN 8 FR X 20 CM
Type of DeviceCATHETER,INTRAVASCULAR,THERAP
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 Key9953549
MDR Text Key187538315
Report Number3006425876-2020-00314
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K900263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/07/2021
Device Catalogue NumberCS-25802-E
Device Lot Number71F19D1540
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/19/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/17/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/13/2020 Patient Sequence Number: 1
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