MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 4-LUMEN 8.5FR X 20CM; CATHETER, PERCUTANEOUS

Catalog Number CV-15854

Device Problem Complete Blockage (1094)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports that during insertion, the white line and grey line were blocked.Once removed, the lines were tested; white line unblocked by force and the grey line unable to unblock.The device was replaced.

Manufacturer Narrative

Qn#(b)(4).The customer returned one 4-lumen catheter and lidstock for evaluation.The catheter contained obvious signs of use in the form of biological material.Visual examination did not reveal any defects or anomalies.The total length of the catheter measured to be 220 mm which is within specifications of 207-227 mm per product drawing.All four lumens were able to flush using a lab inventory syringe with minimal resistance.Biological material was purged when the lines were flushed.A lab inventory guide wire was able to pass through the catheter with minimal resistance.A device history record review was performed with no relevant findings.The ifu provided with this kit instructs the user, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the customer report of blocked extension lines could not be confirmed by complaint investigation of the returned sample.The returned catheter passed all relevant visual, dimensional, and functional testing.No problem was found with the returned sample.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

The customer reports that during insertion, the white line and grey line were blocked.Once removed, the lines were tested; white line unblocked by force and the grey line unable to unblock.The device was replaced.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 20CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8961703
• MDR Text Key: 156582818
• Report Number: 3006425876-2019-00662
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: CV-15854
• Device Lot Number: 71F19D0333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Date Manufacturer Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1