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

Model Number IPN056174

Device Problem Obstruction of Flow (2423)

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

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

Customer reported "the medial (blue) extension line of the cvc was blocked at the hub" during use.The device was replaced.No patient injury or complication reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

Customer reported "the medial (blue) extension line of the cvc was blocked at the hub" during use.The device was replaced.No patient injury or complication reported.The patient's condition is reported as fine.

• Brand Name: ARROW CVC KIT: 3-LUMEN 7 FR X 30CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11143074
• MDR Text Key: 226068530
• Report Number: 3006425876-2021-00054
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• 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: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/02/2022
• Device Model Number: IPN056174
• Device Catalogue Number: DE-24703-TS
• Device Lot Number: 71F20L0310
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.