MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARTERIAL CATH SET: 20GA X 8CM; ARTERIAL CATHETER PRODUCTS

Catalog Number SAC-00820

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2014

Event Type  malfunction  

Event Description

It was reported that this event occurred in the icu.The user reported that the catheter was inserted on (b)(6), and on (b)(6) the catheter had to be replaced as it was "impossible to read the results." there was no delay, harm, complication, death, or injury reported as a result of this occurrence.

Manufacturer Narrative

(b)(4).

• Brand Name: ARTERIAL CATH SET: 20GA X 8CM
• Type of Device: ARTERIAL CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou ; SZ
• Manufacturer Contact: jody cadd, sr. ra specialist ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 3876072
• MDR Text Key: 17617773
• Report Number: 3006425876-2014-00106
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K810675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SAC-00820
• Device Lot Number: ZF3040829
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1