MAUDE Adverse Event Report: ARROW INTERNATIONAL INC CVC KIT: 2-LUMEN 7FR X 20CM; ADULY MULTI-LUMEN CATHETER PRODUCTS

Catalog Number DE-17702-KKR

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Extravasation (1842)

Event Date 09/26/2014

Event Type  Injury  

Event Description

It was reported that this event occurred while the device was in use; in pt's vena subclavia.The user reports that "the catheter slips easily out from the catheter clamp.The paravasat of chemotherapy was penetrating the tissue." as a result, the device was removed and a new catheter was placed to successfully complete the procedure.There was a delay reported, however, there was no reported harm to the pt as a result of this delay.There were no complications or death reported to the pt as a result of this occurrence.There was injury reported, however, specific detail was not available at the time this complaint was submitted.Further info has been requested.

Manufacturer Narrative

(b)(4).Add'l info: this product number is not sold in the us.However, the catheter involved is sold in the us under different product numbers.The 510(k) # provided is for products sold within the us.

• Brand Name: CVC KIT: 2-LUMEN 7FR X 20CM
• Type of Device: ADULY MULTI-LUMEN CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL C.R. A.S.; jamska 2359/47; zdar nad sazavou 591 01; EZ 591 01
• Manufacturer Contact: jody cadd, regulatory affairs ; 2400 bernville rd; reading, PA 19605 ; 6103780131
• MDR Report Key: 4144002
• MDR Text Key: 4914462
• Report Number: 3006425876-2014-00209
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: DE-17702-KKR
• Device Lot Number: 71F14C0419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2014
• Initial Date FDA Received: 10/03/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention