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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB

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ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB Back to Search Results
Catalog Number CDC-42703-XP1A
Device Problems Kinked (1339); Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/12/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Complaint verification testing could not be performed as no sample was returned for analysis. The customer did not supply a batch number, however, potential lot numbers were determined from the sales history for this customer. A device history record review was performed on the guide wire and catheter for the most likely lot number 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 that the wire (spring wire guide) was placed in the patient but the triple lumen would not feed the wire. The guide wire caliber seems bigger than the catheter lumen and it got kinked. There was a short term delay. No patient injury or consequence.
 
Manufacturer Narrative
(b)(4). The results of the investigation are pending at the time of this report.
 
Event Description
The customer reports that the wire (spring wire guide) was placed in the patient but the triple lumen would not feed the wire. The guide wire caliber seems bigger than the catheter lumen and it got kinked. There was a short term delay. No patient injury or consequence.
 
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Brand NameARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB
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 Key6569508
MDR Text Key195660632
Report Number1036844-2017-00226
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/12/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCDC-42703-XP1A
Device Lot NumberUNKNOWN
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 Received07/03/2017
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

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