MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC KIT: 16 GA X 8"; SINGLE LUMEN CVC PRODUCTS

Catalog Number AK-04301-J

Device Problem Air Leak (1008)

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

Event Date 08/10/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during insertion in the patient's room, when the m.D.Was attempting to aspirate blood from the patient's subclavian vein using the raulerson syringe and an 18ga needle, air was aspirated into the syringe.As a result, the needle was immediately removed and a new kit was opened and used without issue.It was noted that it did not seem that the needle punctured the patient's lung.There was no reported delay, death, or complications to the patient as a result of this occurrence.

Manufacturer Narrative

(b)(4).Device evaluation: the reported complaint could not be confirmed.The customer returned one raulerson syringe.However, the introducer needle was not returned.The syringe appeared typical.A vacuum leak test was performed on the syringe several times and it passed each time.Additionally, water was aspirated into the syringe with no air bubbles or signs of leakage.A lab inventory needle was attached to the syringe and water was aspirated through the assembly.Again, there was no signs of a leak.A review of manufacturing records did not yield any relevant findings.The potential cause could not be determined based on the information provided, with no problem found on the syringe and without the needle.No further action will be taken.

• Brand Name: CVC KIT: 16 GA X 8"
• Type of Device: SINGLE LUMEN CVC PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: john george ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 5035015
• MDR Text Key: 24256757
• Report Number: 3006425876-2015-00285
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: AK-04301-J
• Device Lot Number: 71F14D1074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2014
• 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