MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER, PERCUTANEOUS

Catalog Number CS-27702-E

Device Problems Partial Blockage (1065); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/22/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer alleges that the catheter was blocked and the fluid could not pass.The procedure was completed using another device.

Manufacturer Narrative

(b)(4).The customer returned one opened kit with various components.Visual examination of the returned catheter revealed signs of use but no damage or defects were observed.The catheter appeared used but typical.Functional testing was performed by connecting a 10 ml lab inventory syringe filled with water to each extension line hub separately.Pressure was applied to the syringe plunger and water was injected into the catheter and exited at the distal tip and skives accordingly.No resistance was encountered and no blocks were found with both the distal and proximal lumens.A device history record (dhr) review was performed with no relevant findings.The reported complaint that the catheter was found blocked after insertion could not be confirmed through examination and functional testing of the returned sample.No resistance was met and no blocks were found with both the distal and proximal lumens.A dhr review did not reveal any manufacturing related issues.No problem was found with the returned catheter.

Event Description

The customer alleges that the catheter was blocked and the fluid could not pass.The procedure was completed using another device.

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
• 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: 6962180
• MDR Text Key: 90535254
• Report Number: 3006425876-2017-00482
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2017

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: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: CS-27702-E
• Device Lot Number: 71F16B2339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/19/2017
• Initial Date FDA Received: 10/19/2017
• Supplement Dates Manufacturer Received: 11/15/2017
• Supplement Dates FDA Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/29/2016
• 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