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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 14 GA X 6" (16 CM) CATHETER PERCUTANEOUS

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ARROW INTERNATIONAL INC. ARROW CVC SET: 14 GA X 6" (16 CM) CATHETER PERCUTANEOUS Back to Search Results
Catalog Number CS-24706-E
Device Problem Insufficient Information (3190)
Patient Problems Death (1802); Shock (2072)
Event Date 09/06/2020
Event Type  Death  
Manufacturer Narrative

(b)(4). It is unknown if the patient's death was related to the device.

 
Event Description

"on (b)(6) 2020, doctor prepared for the operation to the patient. The deep vein puncture was performed on jugular vein. After the catheter was inserted, the patient's whole body moved in disorder and suffered shock immediately. The rescue failed, and he died on (b)(6). " it was reported "patient was sent into the emergency room for a 2-day period". The hospital was unwilling to disclose more information.

 
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Brand NameARROW CVC SET: 14 GA X 6" (16 CM)
Type of DeviceCATHETER PERCUTANEOUS
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 Key10578075
MDR Text Key208287411
Report Number3006425876-2020-00833
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK862056
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 09/07/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/23/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberCS-24706-E
Device LOT Number71F20A2408
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 Received10/22/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/04/2020
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: 09/23/2020 Patient Sequence Number: 1
Treatment
NONE REPORTED.
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