MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB+; CATHETER,INTRAVASCULAR,THERAP

Catalog Number AK-45703-PB1A

Device Problems Break (1069); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It is reported that the physicians are pulling swg against the bevel of the needle when in the patient to re-adjust.Physician(s)informed that this manipulation is against ifu.

Event Description

The customer reports: the physicians complained about kinking/shearing when they were manipulating it(swg)inside the needle and pulling back against the bevel of the needle.The users have been using different size insertion needle and swg (spring wire guide) combinations.

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: the physicians complained about kinking/shearing when they were manipulating it(swg)inside the needle and pulling back against the bevel of the needle.The users have been using different size insertion needle and swg (spring wire guide) combinations.

Manufacturer Narrative

(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.Based on the report that the customer withdrew the guide wire against the needle bevel, it was determined that user error caused or contributed to this event.An in-service has been initiated for this issue.

Event Description

The customer reports: the physicians complained about kinking/shearing when they were manipulating it(swg)inside the needle and pulling back against the bevel of the needle.The users have been using different size insertion needle and swg (spring wire guide) combinations.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB+
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• 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 Key: 7569399
• MDR Text Key: 110177384
• Report Number: 3003737899-2018-00070
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: AK-45703-PB1A
• Device Lot Number: 13F18B0183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2018
• 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