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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 8" (20 CM) SYRINGE PISTON

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ARROW INTERNATIONAL INC. ARROW CVC SET: 14 GA X 8" (20 CM) SYRINGE PISTON Back to Search Results
Catalog Number CV-50014-BZ
Device Problem Break (1069)
Patient Problem Death (1802)
Event Date 05/05/2020
Event Type  Death  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports that the guide wire broke. Current condition of patient is reported as deceased. There is no report of a patient injury as a result of the alleged issue with the use of the device.
 
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Brand NameARROW CVC SET: 14 GA X 8" (20 CM)
Type of DeviceSYRINGE PISTON
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.
ave. washington 3701
colonia panamericana, chihuahua
chihuahua 31200
MX 31200
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key10116439
MDR Text Key193737451
Report Number9680794-2020-00273
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K781978
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCV-50014-BZ
Device Lot Number14F18C0435
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 Received06/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/06/2018
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: 06/03/2020 Patient Sequence Number: 1
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