MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. UNKNOWN ARTERIAL CATHETER; ARTERIAL CATHETER PRODUCTS

Catalog Number VASCULAR UNKNO

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2014

Event Type  malfunction  

Event Description

It was reported the catheter was placed into the patient's radial artery in the cctc.The catheter functioned twice and then had difficultly drawing blood and was deemed non-functional.Once the catheter was no longer functional it was removed and a new catheter was inserted in an alternate site.The hospital's flushing protocols were noted as: prime and pressurize with ns, flush after blood draws or with zeroing or as needed within the pressurized circuit, usually that equates to 5-10 ml of flush at a time--practice has been like this for some time and has not changed.There was no delay in treatment and no patient death or complications reported.

Manufacturer Narrative

(b)(4).

• Brand Name: UNKNOWN ARTERIAL CATHETER
• Type of Device: ARTERIAL CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce pl.; asheboro NC 27203
• Manufacturer Contact: jody cadd, sr specialist ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 3755419
• MDR Text Key: 15180878
• Report Number: 1036844-2014-00052
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2014

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: VASCULAR UNKNO
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2014
• Initial Date FDA Received: 02/11/2014
• 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