MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 4 FR X 8 CM; CATHETER, PERCUTANEOUS

Catalog Number CS-15402-E

Device Problem Obstruction of Flow (2423)

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

Event Date 09/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer alleges at the time of passing the central catheter an obstruction is evident.The device was replaced without complications.

Manufacturer Narrative

(b)(4).The customer returned one catheter attached to a 10 ml syringe for evaluation.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 of the catheter was found blocked during use 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 at the time of passing the central catheter an obstruction is evident.The device was replaced without complications.

• Brand Name: ARROW CVC SET: 2-LUMEN 4 FR X 8 CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6966058
• MDR Text Key: 90197937
• Report Number: 9680794-2017-00241
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: CS-15402-E
• Device Lot Number: 14F17D0058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2017
• 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: 7 YR