MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM; ACUTE HEMODIALYSIS CATHETER PRODUCTS

Catalog Number CV-12122-F

Device Problems Kinked (1339); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that guide wire and dilator reportedly bends easily.Resistance was met when introducing the dilator.As a result, a new kit was opened and used without issue.There was no reported delay, death, or complications to the patient as a result of this occurrence.

Manufacturer Narrative

(b)(4).Device evaluation: the reported complaint for resistance between the guide wire and dilator could not be confirmed.One sterile hemodialysis kit was returned for evaluation.The actual complaint sample was not returned.Visual examination revealed the kit appears typical with no damage or defect observed.All components listed in the bom are inside.Upon further inspection, the dilator tip is damaged.The guide wire and catheter are typical with no damage or defect observed.The guide wire measures 601 mm from end to end and has an outside diameter (od) of 0.861 mm.Both measurements are within specification of 596- 604 mm and 0.838- 0.877 mm per graphic.The dilator hub is white and there are two tapers to the dilator body each narrowing slightly from the hub to the distal tip.The length of the dilator is 5.43" from the bottom of the hub to the distal tip.This is within specification of 5.25- 5.75" per graphic.The dilator tip could not be accurately measured due to the damage observed.The catheter is a 2-l, 7 fr, 16 cm hemodialysis catheter.The catheter body measures 167 mm from the bottom of the juncture hub to the distal tip).This is within specification of 157- 177 mm per graphic.Functional testing other remarks: was performed by attempting to pass the returned guide wire through both the dilator and catheter that were returned.There was no issue passing the guide wire through the dilator or catheter.A device history record review did not reveal any manufacturing related issues.Since the actual complaint sample was not returned, the probable cause could not be determined.No further action will be taken.

• Brand Name: HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM
• Type of Device: ACUTE HEMODIALYSIS CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 5519842
• MDR Text Key: 40964561
• Report Number: 3006425876-2016-00085
• Device Sequence Number: 1
• Product Code: LFJ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K895417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: CV-12122-F
• Device Lot Number: 71F15C0794
• Other Device ID Number: 00801902001184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2015
• 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