MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 8.5FR X 16CM; CATHETER, PERCUTANEOUS

Catalog Number CV-12853

Device Problems Partial Blockage (1065); Failure to Advance (2524)

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

Event Date 12/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information: the patient died 5 days after the incident.The death is not linked to this incident per information from medical staff.In the death report it is stated that the patient had persistence of encephalopathy.The patient's family was informed of the seriousness of the situation, the various episodes of complication and the extremely limited prognosis of the situation.After a collegial decision, it was decided to stop care and continue with comfort care.

Event Description

The customer alleges during insertion of the catheter, it was impossible to advance the catheter through the stylet because there was a blockage at the level of the 3 lumen hub.The catheter was replaced.

Manufacturer Narrative

(b)(4).Corrected data: the initial mdr, submitted on 01/09/2018, was sent in error.The event reported was determined to be not reportable.

Event Description

The customer alleges during insertion of the catheter, it was impossible to advance the catheter through the stylet because there was a blockage at the level of the 3 lumen hub.The catheter was replaced.

• Brand Name: ARROW CVC SET: 3-LUMEN 8.5FR X 16CM
• Type of Device: CATHETER, PERCUTANEOUS
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7175023
• MDR Text Key: 96815549
• Report Number: 3006425876-2018-00025
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/22/2017

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: No Information
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: CV-12853
• Device Lot Number: 71F17L1594
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2017
• Initial Date FDA Received: 01/09/2018
• Supplement Dates Manufacturer Received: 12/22/2017
• Supplement Dates FDA Received: 02/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2017
• 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
• Patient Age: 81 YR