MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 3-LUMEN 7 FR X 20 CM; ARROWG+ARD CATHETER PRODUCTS

Catalog Number CS-25703-E

Device Problems Fluid/Blood Leak (1250); Aspiration Issue (2883)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that after inserting the introducer needle into the patient's vein, the physician was unable to aspirate.The raulerson syringe was then tested and at that time was found to leak.As a result, new kit was opened and used without issue.A delay was reported, however, there was no additional harm to the patient due to this delay or as a result of this occurrence.

Manufacturer Narrative

(b)(4).Device evaluation: the report that the arrow raulerson syringe (ars) was found leaking when attempting to aspirate from the vein was not confirmed.Returned was one raulerson syringe/introducer needle assembly.The ars syringe appeared typical.The luer taper at the tip of the syringe was found to be acceptable.A vacuum leak test was performed on the ars.With the plunger body at the bottom of the syringe, the tip of the ars was occluded and the plunger was pulled back until it stopped.With the tip of the ars still occluded, the plunger was released and it returned to its original position, which passed the test.The needle appeared typical.The luer taper of the hub passed luer gage testing.The needle attached firmly to the ars syringe.Water was aspirated into the assembly five times with no air bubbles or signs of a leak.A review of the device history records for the ars / needle assembly did not reveal any manufacturing related issues.The ars passed vacuum testing and the ars/needle assembly did not leak during functional aspiration testing.No problem was found on the sample.No further action will be taken.

• Brand Name: CVC SET: 3-LUMEN 7 FR X 20 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: 5417532
• MDR Text Key: 38168885
• Report Number: 1036844-2016-00086
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 02/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: CS-25703-E
• Device Lot Number: 23F15F1365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2015
• 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