MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 12 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Model Number IPN030093

Device Problem Obstruction of Flow (2423)

Patient Problems No Consequences Or Impact To Patient (2199); Therapeutic Response, Decreased (2271)

Event Date 09/30/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 on a potential lot number 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

Customer reported "catheter had to be removed 10 hours before, because a structure (possibly tissue) was deposited inside the catheter and the catheter was blocked".It was reported the catheter was in place for four days.The patient was reported to be critical prior to insertion of the catheter and suffering from multiorgan collapse and sepsis.It was reported therapy was stopped and no blood return was possible.Dialysis was delayed and patient required a blood transfusion due to the delay.A new device was planned to be placed.The patient's condition was reported to be fine at the time of this report.

• Brand Name: ARROW CVC SET: 3-LUMEN 12 FR X 20 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• 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: victoria sandlin ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 10720670
• MDR Text Key: 212560022
• Report Number: 3006425876-2020-00894
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K970864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IPN030093
• Device Catalogue Number: CS-15123-F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: NONE REPORTED.
• Patient Outcome(s): Required Intervention