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

Catalog Number CS-15242-VSP

Device Problem Material Fragmentation (1261)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/16/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Sample will not be returned.

Event Description

It was reported that this event occurred in the operating room.The insertion site was the jugular vein.While inserting the catheter, one side of the smartseal became broken and went into the sheath.It was not possible to advance the catheter.The physician opened the sheath, removed the piece, and advanced the catheter into the correct position and finished the procedure as usual.As a result, the pt had a hemorrhage, but it did not cause relevant injuries to the pt.There was no reported delay in treatment.

• Brand Name: HEMODIALYSIS KIT: 2-L 15 FR X 19 CM
• Manufacturer (Section D): ARROW INTL., INC.; reading PA
• Manufacturer (Section G): ARROW INTL., INC.; 312 commerce pl.; asheboro NC 27203
• Manufacturer Contact: john george, ra specialist ; 2400 bernville rd; reading, PA 19605
• MDR Report Key: 4562209
• MDR Text Key: 16591361
• Report Number: 1036844-2015-00069
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: CS-15242-VSP
• Device Lot Number: 23F14G0666
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2015
• Initial Date FDA Received: 03/02/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 45 YR