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

Catalog Number CS-15242-SP

Device Problems Fracture (1260); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2014

Event Type  malfunction  

Event Description

It is reported this event occurred in the dialysis department.The catheter was in place for six months in the pt's jugular vein.There was leaking noted at the hub connection.When the physician examined the catheter more closely, he found a crack on the luer connection.As a result, the catheter was replaced successfully with a new one.There was no reported delay in treatment.There was no reported pt injury, complication, or death.A second mdr will be filed for this occurrence due to multiple events with the same device.The mdr # is 1036844-2014-00502.

Manufacturer Narrative

(b)(4).The additional mdr was filed for this event because the issue was discovered on two separate luer connections.

• Brand Name: HEMODIALYSIS KIT: 2-L 15 FR X 19 CM
• Type of Device: ACUTE HEMODIALYSIS CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTL., INC.; reading PA
• Manufacturer (Section G): ARROW INTL., INC.; 312 commerce pl.; asheboro NC 27203
• Manufacturer Contact: john george, specilaist ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 4347263
• MDR Text Key: 17279207
• Report Number: 1036844-2014-00501
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K111117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CS-15242-SP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2014
• Was Device Evaluated by Manufacturer?: No
• 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