MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. 3-L CVC KIT: 7 FR X 20 CM; ARROWG+ARD CATHETER PRODUCTS

Catalog Number CDC-45703-A1A

Device Problems Bent (1059); Material Frayed (1262); Physical Resistance (2578)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report is the second of two consecutive product problems with the same patient.The first issue has been reported under mdr# 1036844-2016-00202.

Event Description

Per the complaint investigation of the samples received the dilator was also returned and was found to be damaged from resistance with the guide wire kinking.

Manufacturer Narrative

(b)(4).Device evaluation: the reported complaint of difficulty during insertion was confirmed.The customer returned one dilator.Visual examination of the returned dilator revealed that the body is slightly bent and the tip is damaged.Microscopic examination confirmed that the tip is flared out like a petal.White stress marks can be seen around the damaged tip.This type of damage is consistent with a difficult insertion and with the guide wire being pulled against the tip either during insertion or removal.The dilator was measured at 10.0 cm which is within specification of 3.75-4.25 in (9.525-10.795 cm) per dilator graphic.The outside diameter of the dilator body is 0.112 in.This is within specification of 0.111-0.113 in.Per dilator graphic.The ifu for this product states to enlarge the puncture site with the cutting edge of a scalpel positioned away from the guide wire which is already inserted into the patient.The insertion procedure used was not reported and therefore it is not known if a skin nick was performed prior to dilator insertion.The device history record review were reviewed and did not reveal any manufacturing related issues.Based upon the time of discovery and the information provided, operational context caused or contributed to this complaint.No further action will be taken.

• Brand Name: 3-L CVC KIT: 7 FR X 20 CM
• Type of Device: ARROWG+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 Key: 5571614
• MDR Text Key: 42496352
• Report Number: 1036844-2016-00212
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: CDC-45703-A1A
• Device Lot Number: 23F15F1240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2015
• 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