MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 30 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-24703-E

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The complaint is reported as: "the catheter has blockage issue." the device was removed in its entirety and replaced.No patient harm, or complication reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer returned one 3-lumen cvc for evaluation.Visual examination of the returned sample did not reveal any defects or anomalies.No kinks or damage was observed.The total length of the catheter body measured to be 320 mm which is within specifications of 310-330 mm per product drawing.All three lumens were flushed using a lab inventory syringe.The distal lumen flushed with minimal resistance.When the proximal and medial lumens were flushed, resistance was encountered.Significant biological material was cleared from the lines, then the catheter flushed as expected.A lab inventory guide wire was able to pass through the returned catheter with minimal resistance.A device history record review was performed with no relevant findings.The ifu provided with this kit cautions the user, "ensure catheter patency prior to use.Do not use syringes smaller than 10 ml (a fluid filled 1 ml syringe can exceed 300 psi) to reduce risk of intraluminal leakage or catheter rupture." the customer report of a blocked catheter was confirmed by complaint investigation of the returned sample.The catheter contained a significant amount of biological material build up in the catheter.A device history record review was performed with no relevant findings.Based on the condition of the sample received, unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

The complaint is reported as: "the catheter has blockage issue." the device was removed in its entirety and replaced.No patient harm or complication reported.The patient's condition is reported as fine.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 30 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10982812
• MDR Text Key: 220673455
• Report Number: 3006425876-2020-01013
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

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: 01/26/2022
• Device Catalogue Number: CS-24703-E
• Device Lot Number: 71F20C2921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 12/17/2020
• Supplement Dates FDA Received: 12/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1