MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 16CM AGB+; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number ASK-42703-PUHC

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).The results of the investigation are pending at the time of this report.

Event Description

The customer reports the wire was placed into 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).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 the wire was placed into 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.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 16CM AGB+
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• 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 Key: 6569026
• MDR Text Key: 75332340
• Report Number: 1036844-2017-00221
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: ASK-42703-PUHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/03/2017
• 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
• Patient Sequence Number: 1