MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 4-LUMEN 8.5FR X 20CM; CATHETER INTRAVASCULAR THERAPE

Model Number IPN918714

Device Problem Material Separation (1562)

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

Event Date 03/08/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported during puncture of the right subclavian vein (without ultrasound), the needle hub broke and separated.There was no patient harm.No medical intervention was required.The device was replaced.

Event Description

It was reported during puncture of the right subclavian vein (without ultrasound), the needle hub broke and separated.There was no patient harm.No medical intervention was required.The device was replaced.

Manufacturer Narrative

Qn# (b)(4).The customer returned one introducer needle for analysis.Signs of use in the form of biological material were present in the hub.Visual analysis revealed that the needle hub was broken and separated.A portion of the distal end of the hub was still adhered to the needle cannula.Microscopic examination revealed that the point of separation was smooth.Functional inspection was not able to be performed due to the damage to the needle hub.A device history record review was performed with no relevant findings.The report of a separated needle hub was confirmed by complaint investigation of the returned sample.Visual examination revealed the hub was separated.A device history record review was performed, and no relevant findings were identified.Based on the sample provided, design likely caused or contributed to this event.A capa was opened to further investigate this issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 20CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• 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: 13943235
• MDR Text Key: 288182439
• Report Number: 3006425876-2022-00268
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: IPN918714
• Device Catalogue Number: EU-15854-CVT
• Device Lot Number: 71F21J1048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2021
• 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: OCTENIDERM DISINFECTANT; OCTENIDERM DISINFECTANT