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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. PI MULTI-LUMEN CVC KIT: 4-LUMEN 8.5 FR X ARROWG+ARD CATHETER PRODUCTS

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ARROW INTERNATIONAL INC. PI MULTI-LUMEN CVC KIT: 4-LUMEN 8.5 FR X ARROWG+ARD CATHETER PRODUCTS Back to Search Results
Catalog Number ASK-42854-PNMM
Device Problems Kinked (1339); Physical Resistance (2578)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/11/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the physician was experiencing difficulty with the guide wire catching on the needle when they are attempting to remove the needle over the wire. This has caused the wire to become kinked. As a result, they are using a larger wire for the procedure.
 
Manufacturer Narrative
(b)(4). Device evaluation: complaint verification testing could not be performed because no sample was returned. The device history records for the guide wire and introducer needle were reviewed with no evidence to suggest a manufacturing related cause. The probable cause for difficulty with needle removal over the guide wire could not be determined based upon the information provided and without a sample. No further action will be taken.
 
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Brand NamePI MULTI-LUMEN CVC KIT: 4-LUMEN 8.5 FR X
Type of DeviceARROWG+ARD CATHETER PRODUCTS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
312 commerce place
asheboro NC 27203
Manufacturer Contact
jamie hartz
2400 bernville road
reading, PA 19605
MDR Report Key5659232
MDR Text Key45302685
Report Number1036844-2016-00266
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/11/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/17/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2017
Device Catalogue NumberASK-42854-PNMM
Device Lot Number23F15K0286
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 Received07/15/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/07/2015
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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