MAUDE Adverse Event Report: ARROW INTL., INC. HEMODIALYSIS KIT: 2-L 15 FR X 23 CM; CRONIC HEMODIALYSIS CATHETERS

Catalog Number CS-15282-VSP

Device Problem Air Leak (1008)

Patient Problem No Information (3190)

Event Date 07/24/2014

Event Type  malfunction  

Event Description

This complaint was submitted with very little information.It was reported that "at the point of the olive, when confirming the extension piece to the catheter, it leaks air".No further information was available at the time of submission.

Manufacturer Narrative

(b)(4).

• Brand Name: HEMODIALYSIS KIT: 2-L 15 FR X 23 CM
• Type of Device: CRONIC HEMODIALYSIS CATHETERS
• Manufacturer (Section D): ARROW INTL., INC.; reading PA
• Manufacturer (Section G): ARROW INTL., INC.; 312 commerce pl.; asheboro NC 27203
• Manufacturer Contact: jody cadd ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 4071629
• MDR Text Key: 15126433
• Report Number: 1036844-2014-00343
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K040078
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CS-15282-VSP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2014
• Initial Date FDA Received: 08/12/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1