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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7 FR X 20 CM CATHETER PERCUTANEOUS
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ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7 FR X 20 CM CATHETER PERCUTANEOUS Back to Search Results
Catalog Number CV-17702-BZ
Device Problem Break (1069)
Patient Problems Death (1802); No Known Impact Or Consequence To Patient (2692)
Event Date 10/03/2019
Event Type  Death  
Manufacturer Narrative

(b)(4). It is reported that the patient died, but the non-compliance did not cause the patient's death per additional information received.

 
Event Description

The customer reports that when the doctor attempted to puncture (skin perforation) the needle broke. A new kit was used. No intervention reported.

 
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Brand NameARROW CVC SET: 2-LUMEN 7 FR X 20 CM
Type of DeviceCATHETER PERCUTANEOUS
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 Key9746775
MDR Text Key180632825
Report Number9680794-2020-00085
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeBR
PMA/PMN NumberK862056
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 01/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/24/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberCV-17702-BZ
Device LOT Number14F18G0440
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/21/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/13/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/07/2018
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: 02/24/2020 Patient Sequence Number: 1
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