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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 3-LUMEN 7 FR X 20 CM CATHETER, INTRAVASCULAR, THERAPEUTIC

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ARROW INTERNATIONAL INC. ARROW CVC KIT: 3-LUMEN 7 FR X 20 CM CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
Catalog Number AK-45703-ACDC
Device Problem Difficult or Delayed Positioning (1157)
Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)
Event Date 04/09/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). It is reported there was no patient injury. However, it's reported a stick to the user. No additional information provided.
 
Event Description
The customer reports there was a problem deploying the new scalpel which resulted in a stick. No patient injury. User stick.
 
Manufacturer Narrative
Qn# (b)(4). Complaint verification testing could not be performed as no sample was returned for analysis. A device history record review was performed and 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 there was a problem deploying the new scalpel which resulted in a stick. No patient injury. User stick.
 
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Brand NameARROW CVC KIT: 3-LUMEN 7 FR X 20 CM
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V
ave. washington 3701, edificio 4
colonia complejo industrial, las americas
chihuahua 31114
MX 31114
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key7465783
MDR Text Key106656628
Report Number3003737899-2018-00038
Device Sequence Number1
Product Code FOZ
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 04/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2018
Device Catalogue NumberAK-45703-ACDC
Device Lot Number13F17H0309
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 Received05/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/15/2017
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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