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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CANNON II PLUS REPLACEMENT HUB SET; KIT, REPAIR, CATHETER, HEMODI

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ARROW INTERNATIONAL INC. ARROW CANNON II PLUS REPLACEMENT HUB SET; KIT, REPAIR, CATHETER, HEMODI Back to Search Results
Catalog Number CAR-02400
Device Problem Crack (1135)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/12/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports that a patient had a pemcath inserted 2 months ago, and a week ago presented with a cracked hub on one of the lumen, they changed the hub and inserted car02400, she has now returned with the hub leaking (documented in mdr# 1036844-2017-00456).
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The lot number was not provided by the customer; therefore, a device history record review was performed based on the sales history of the customer.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 that a patient had a pemcath inserted 2 months ago, and a week ago presented with a cracked hub on one of the lumen, they changed the hub and inserted car02400, she has now returned with the hub leaking (documented in mdr# 1036844-2017-00456).
 
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Brand Name
ARROW CANNON II PLUS REPLACEMENT HUB SET
Type of Device
KIT, REPAIR, CATHETER, HEMODI
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
312 commerce place
asheboro NC 27203
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key7148504
MDR Text Key96151790
Report Number1036844-2017-00455
Device Sequence Number1
Product Code NFK
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K020430
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberCAR-02400
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/13/2017
Initial Date FDA Received12/27/2017
Supplement Dates Manufacturer Received02/06/2018
Supplement Dates FDA Received02/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age32 YR
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