MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 2-LUMEN 4 FR X 13 CM; ARROWG+ARD CATHETER PRODUCTS

Catalog Number CS-24402

Device Problems Kinked (1339); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during insertion in ped, the md was unable to advance the guide wire through the introducer needle due to severe resistance.As a result, a new kit was opened and used without issue.There was no reported delay, death, or complications to the patient as a result of this occurrence.

Manufacturer Narrative

Qn#(b)(4).Device evaluation: the reported complaint of unable to advance the guide wire through the introducer needle due to severe resistance was not confirmed by evaluation of the returned sample.While the returned guide wire was kinked in three places, the guide wire was not the same diameter as the one provided in the reported cs-24402 kit.No information could be obtained regarding the discrepancy.A device history record review was performed and did not reveal any manufacturing related issues.There was no evidence to indicate that an incorrect guide wire was placed in the kit.Additionally, the introducer needle involved in the incident was not returned.Based on these circumstances, the probable cause of this issue could not be determined.No further action will be taken.

Event Description

E.

• Brand Name: CVC SET: 2-LUMEN 4 FR X 13 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 ; 6103780131
• MDR Report Key: 5428856
• MDR Text Key: 37982808
• Report Number: 1036844-2016-00112
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: CS-24402
• Device Lot Number: 23F14B0924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2014
• 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