MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. RA CATH SET: 20 GA X 1-1/2; ARTERIAL CATHETER PRODUCTS

Catalog Number RA-04220

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2014

Event Type  malfunction  

Event Description

It was reported that an arterial line was inserted into the (b)(6) male patient's right radial artery under ultrasound with no complications.The user reported that the line functioned for 3 minutes.The user was unable to pick up waveform readings and was unable to perform a blood draw.The patient was sedated on inotropic support, so there was no movement from the patient.As a result, the device was removed and a new radial catheter was placed into the patient's left radial artery to successfully perform the procedure.There was no delay, death, complication, or harm to the patient as a result of this occurrence.

Manufacturer Narrative

(b)(4).

• Brand Name: RA CATH SET: 20 GA X 1-1/2
• Type of Device: ARTERIAL CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; chihuahua 3120 0; MX 31200
• Manufacturer Contact: jody cadd, sr, ras ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 3843682
• MDR Text Key: 4679721
• Report Number: 9680794-2014-00076
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: RA-04220
• Device Lot Number: 14F13K0041
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 50 YR