MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. PI CVC KIT: 3-L 7 FR X 16 CM AGB+; ARROWG+ARD CATHETER PRODUCTS

Catalog Number CA-42703-P1A

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No sample will be returned for evaluation.

Event Description

It was reported the catheter as placed into the left internal jugular of a patient in the intensive care unit.The proximal lumen was discovered to be blocked.Cathflo was installed to unblock the lumen and left to dwell.When the nurse returned and tried to access/flush she determined that the fluid was going onto the linen of the bed and subsequently discovered a hole in the proximal lumen.As a result, a new catheter was placed.They do not know if there was a delay in treatment but there was no patient death or complications reported.

• Brand Name: PI CVC KIT: 3-L 7 FR X 16 CM AGB+
• Type of Device: ARROWG+ARD CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: john george ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 5333778
• MDR Text Key: 34642764
• Report Number: 1036844-2015-00600
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/09/2015

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: CA-42703-P1A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2015
• Initial Date FDA Received: 12/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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