MAUDE Adverse Event Report: ARROW INTERNATIONAL C.R. A.S. CVC SET: 4-LUMEN 8.5FR X 16CM; ADULT MULTI-LUMEN CATHETER PRODUCTS

Catalog Number CS-12854-E

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the insertion site was the right internal jugular vein on (b)(6) 2014.When they flushed the catheter they noted the catheter had migrated out and there was only a couple of centimeters remaining in the vessel.The exit holes were visible and the infusions were not infusing.The vascular nurse was called and pulled the catheter out on (b)(6) 2014.The cvc was removed and the patient was transferred from the surgical ward to radiology for an urgent insertion of a picc in the right internal jugular.This was a result of the insulin infusion having to be stopped and the patient's blood sugar was high and they needed to recommence as soon as possible.The patient was also experiencing significant pain as there was no pca and was dehydrated as there were no fluids.A delay was reported, however, there was no reported death or complications to the patient as a result of this occurrence.

• Brand Name: CVC SET: 4-LUMEN 8.5FR X 16CM
• Type of Device: ADULT MULTI-LUMEN CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL C.R. A.S.; jamska 235947; zdar nad sazavou 0000
• Manufacturer (Section G): ARROW INTERNATIONAL C.R. A.S.; jamska 235947; zdar nad sazavou 5910 1; EZ 59101
• Manufacturer Contact: alice harper ; 2400 bernville rd.; reading, PA 19605 ; 6103780131
• MDR Report Key: 4289011
• MDR Text Key: 19368354
• Report Number: 3006425876-2014-00243
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K862056
• 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: 10/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: CS-12854-E
• Device Lot Number: 71F14A0329
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2014
• Initial Date FDA Received: 11/11/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2014
• 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