MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC KIT: 2-LUMEN 4 FR X 5 CM ARROWG+ARD CATHETER PRODUCTS

Catalog Number AK-22402

Device Problems Physical Resistance (2578); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the kit was used for central line placement, and the 22ga catheter in kit was used for arterial line placement. It was successful line placement, however, the catheter hub would not luer lock in place. This is what the medical doctor typically uses, and by reports, anesthesia as well. The line had to be rewired using another catheter, and rewire of line was unsuccessful, and arterial access was obtained in the patient. There was no reported patient injury or consequences as a result of this occurrence.

Manufacturer Narrative

Qn#(b)(4). Device evaluation: the reported complaint of the 22 ga catheter from the over needle assembly did not lock in place could not be confirmed since no sample was returned for evaluation. However, the reported information states that the 22 ga catheter was used to access an artery and act as an indwelling arterial catheter. The ifu for this product states that the 22 ga catheter over needle assembly can be used for accessing the vein prior to the cvc catheter insertion and does not state that the 22ga catheter can be used as an indwelling catheter. A device history record review did not reveal any manufacturing related issues. The potential cause of the 22ga catheter luer hub connection issues could not be determined based upon the information provided and without a sample; however, use error appears to have contributed to this complaint since the 22 ga catheter was used for an off label function. An in-service was requested for this complaint.

• Brand Name: CVC KIT: 2-LUMEN 4 FR X 5 CM
• 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: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 5826704
• MDR Text Key: 50581308
• Report Number: 1036844-2016-00436
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 07/17/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 08/31/2017
• Device Catalogue Number: AK-22402
• Device Lot Number: 23F15M0293
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial