MAUDE Adverse Event Report: ARROW INTL., INC. HEMODIALYSIS KIT: 2-L 15 FR X 19 CM; CHRONIC HEMODIALYSIS PRODUCTS

Catalog Number CS-15242-SP

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/20/2014

Event Type  malfunction  

Event Description

It was reported that when the doctor was to dialyze the pt, he found blood and a crack on the luer connector of the catheter placed in the pt's jugular vein.As a result, a new kit was opened and used without issue.There was no reported delay, death, or complications to the pt as a result of this occurrence.

Manufacturer Narrative

(b)(4).

• Brand Name: HEMODIALYSIS KIT: 2-L 15 FR X 19 CM
• Type of Device: CHRONIC HEMODIALYSIS PRODUCTS
• Manufacturer (Section D): ARROW INTL., INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce pl.; asheboro NC 27203
• Manufacturer Contact: john george, specialist ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 4366294
• MDR Text Key: 5291052
• Report Number: 1036844-2014-00533
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• PMA/PMN Number: K111117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/10/2014

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 Expiration Date: 11/30/2016
• Device Catalogue Number: CS-15242-SP
• Device Lot Number: 23F13L0118
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/18/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2014
• Initial Date FDA Received: 12/22/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2013
• 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
• Patient Age: 45 YR