MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CVC SET: 3-LUMEN 7FR X 20CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number SA-25703-EU

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 12/21/2023

Event Type  malfunction  

Event Description

It was reported that "as per the stock controller , when the doctor inserted the needle during insertion of the cvc the doctor tried to withdraw and then noticed the needle as being faulty as it was 'leaking'.Clinical consequences: procedure stopped and another new set opened and only needle used from there to continue with the insertion process.The 'faulty' needle was discarded by the hospital staff." there was no reported patient harm or consequence.Additional information: the needle hub was cracked.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "as per the stock controller , when the doctor inserted the needle during insertion of the cvc the doctor tried to withdraw and then noticed the needle as being faulty as it was 'leaking'.Clinical consequences: procedure stopped and another new set opened and only needle used from there to continue with the insertion process.The 'faulty' needle was discarded by the hospital staff." there was no reported patient harm or consequence.Additional information: the needle hub was cracked.

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.

• Brand Name: CVC SET: 3-LUMEN 7FR X 20CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18847610
• MDR Text Key: 337020490
• Report Number: 3006425876-2024-00218
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SA-25703-EU
• Device Lot Number: 71F23D0924
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2023
• 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: NOT REPORTED; NOT REPORTED